The Effects of Plantar Flexion Training in People With Chronic Stroke

NCT03548090 | Completed

• 1 other identifier: HSC-MH-17-0284
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study consists of three phases that aim to develop an exercise intervention to promote maximal activation of ankle plantar flexors in the paretic lower extrimty (LE) in order to restore a more normalized gait pattern in chronic stroke survivors. The aim of the first phase is to determine if there are differences between standing on different levels of inclination on plantar flexion activation during forward movement of the contralateral LE in adults with chronic with stroke. The aim of second phase is to determine if there are differences between different percentages of weight bearing on the paretic LE on plantar flexion activation during forward movement of the contralateral LE in adults with chronic stroke. The aim of the third phase is to determine if there are differences between a 4-week plantar flexion training intervention and conventional physical therapy.

Conditions

Stroke; Hemiplegic Gait

Keywords

stroke rehabilitation; walking limitations; gait rehabilitation

Outcome Measures

Primary Outcomes (6)

• Step length asymmetry ratio as assessed by the GAITRite®

  The step length asymmetry ratio will be calculated by dividing the paretic step length by non-paretic step lengths. The magnitude of the ratio indicates the nature of the asymmetry, with symmetrical gait defined as step length ratio of 0.9-1.1, and asymmetrical gait where the non-paretic step lengths are longer than the paretic step lengths with any step length ratio greater than 1.1.

  baseline, 6 weeks (relative to the phase 3 intervention)

• Muscle activity of the medial gastrocnemius as assessed by surface EMG

  Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of medial gastrocnemius muscle in the paretic lower extremity (LE).

  on the 1 day of the phase 1 intervention

• Muscle activity of the soleus as assessed by surface EMG

  Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of soleus muscle in the paretic lower extremity (LE).

  on the 1 day of the phase 1 intervention

• Plantar flexion torque as assessed by isokinetic dynamometry

  Peak plantar flexion torque will be acquired using an isokinetic dynamometer(Biodex Medical Systems, Shirely, New York, USA). Calibration of the Biodex® will be performed prior to the assessment of each individual. For each participant, the plantar flexors will be warmed-up on a LE ergometer for 10 minutes prior to testing. The participant will be fully secured to prevent compensatory behaviors from trunk or hips that may influence results. A pre-speed warm up on the Biodex of three submaximal repetitions and one maximal repetition will be conducted prior to testing so the participant understands what these repetitions feel like. The angular velocity will be set a 60°/second, five repetitions will be performed, and the peak torque of the plantar flexors will be collected.

  baseline, 6 weeks (relative to the phase 3 intervention)

• Muscle activity of the medial gastrocnemius as assessed by surface EMG

  Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of medial gastrocnemius muscle in the paretic lower extremity (LE).

  on the 1 day of the phase 2 intervention

• Muscle activity of the soleus as assessed by surface EMG

  Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of soleus muscle in the paretic lower extremity (LE).

  on the 1 day of the phase 2 intervention

Secondary Outcomes (4)

• Gait speed as assessed by the GAITRite®

  baseline, 6 weeks (relative to the phase 3 intervention)

• Muscle activity of the medial gastrocnemius as assessed by surface EMG

  baseline, 6 weeks (relative to the phase 3 intervention)

• Muscle activity of the soleus as assessed by surface EMG

  baseline, 6 weeks (relative to the phase 3 intervention)

• Quality of life as assessed by the Stroke Impact Scale

  baseline, 6 weeks (relative to the phase 3 intervention)

Study Arms (24)

1

EXPERIMENTAL

Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 75%, then 90%), Phase 3 (control 4-week exercise intervention)

Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Control 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise

2

EXPERIMENTAL

Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 90%, then 75%), Phase 3 (control 4-week exercise intervention)

Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Control 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise

3

EXPERIMENTAL

Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 50%, then 90%), Phase 3 (control 4-week exercise intervention)

Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Control 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise

4

EXPERIMENTAL

Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 90%, then 50%), Phase 3 (control 4-week exercise intervention)

Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Control 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise

5

EXPERIMENTAL

Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 50%, then 75%), Phase 3 (control 4-week exercise intervention)

Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Control 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise

6

EXPERIMENTAL

Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 75%, then 50%), Phase 3 (control 4-week exercise intervention)

Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Control 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise

7

EXPERIMENTAL

Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 75%, then 90%), Phase 3 (control 4-week exercise intervention)

Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Control 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise

8

EXPERIMENTAL

Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 90%, then 75%), Phase 3 (control 4-week exercise intervention)

Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Control 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise

9

EXPERIMENTAL

Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 50%, then 90%), Phase 3 (control 4-week exercise intervention)

Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Control 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise

10

EXPERIMENTAL

Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 90%, then 50%), Phase 3 (control 4-week exercise intervention)

Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Control 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise

11

EXPERIMENTAL

Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 50%, then 75%), Phase 3 (control 4-week exercise intervention)

Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Control 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise

12

EXPERIMENTAL

Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 75%, then 50%), Phase 3 (control 4-week exercise intervention)

Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Control 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise

13

EXPERIMENTAL

Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 75%, then 90%), Phase 3 (experimental 4-week exercise intervention)

Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Experimental 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise

14

EXPERIMENTAL

Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 90%, then 75%), Phase 3 (experimental 4-week exercise intervention)

Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Experimental 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise

15

EXPERIMENTAL

Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 50%, then 90%), Phase 3 (experimental 4-week exercise intervention)

Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Experimental 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise

16

EXPERIMENTAL

Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 90%, then 50%), Phase 3 (experimental 4-week exercise intervention)

Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Experimental 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise

17

EXPERIMENTAL

Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 50%, then 75%), Phase 3 (experimental 4-week exercise intervention)

Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Experimental 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise

18

EXPERIMENTAL

Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 75%, then 50%), Phase 3 (experimental 4-week exercise intervention)

Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Experimental 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise

19

EXPERIMENTAL

Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 75%, then 90%), Phase 3 (experimental 4-week exercise intervention)

Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Experimental 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise

20

EXPERIMENTAL

Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 90%, then 75%), Phase 3 (experimental 4-week exercise intervention)

Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Experimental 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise

21

EXPERIMENTAL

Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 50%, then 90%), Phase 3 (experimental 4-week exercise intervention)

Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Experimental 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise

22

EXPERIMENTAL

Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 90%, then 50%), Phase 3 (experimental 4-week exercise intervention)

Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Experimental 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise

23

EXPERIMENTAL

Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 50%, then 75%), Phase 3 (experimental 4-week exercise intervention)

Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Experimental 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise

24

EXPERIMENTAL

Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 75%, then 50%), Phase 3 (experimental 4-week exercise intervention)

Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Experimental 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise

Interventions

Skateboard exercise at an incline angle of 0 degrees and 50% body weight OTHER

Participants will stand on a specified incline angle (0 degrees) and with a specified body weight (50%) on the paretic LE and will simultaneously move a small skateboard forward with the non-paretic LE.

1; 10; 11; 12; 13; 14; 15; 16; 17; 18; 19; 2; 20; 21; 22; 23; 24; 3; 4; 5; 6; 7; 8; 9

Skateboard exercise at an incline angle of 5 degrees and 50% body weight OTHER

Participants will stand on a specified incline angle (5 degrees) and with a specified body weight (50%) on the paretic LE and will simultaneously move a small skateboard forward with the non-paretic LE.

1; 10; 11; 12; 13; 14; 15; 16; 17; 18; 19; 2; 20; 21; 22; 23; 24; 3; 4; 5; 6; 7; 8; 9

Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight OTHER

Participants will stand on a specified incline angle (either 0 or 5 degrees, whichever is determined during phase 1 to be optimal) and with a specified body weight (75%) on the paretic LE and will simultaneously move a small skateboard forward with the non-paretic LE.

1; 10; 11; 12; 13; 14; 15; 16; 17; 18; 19; 2; 20; 21; 22; 23; 24; 3; 4; 5; 6; 7; 8; 9

Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight OTHER

Participants will stand on a specified incline angle (either 0 or 5 degrees, whichever is determined during phase 1 to be optimal) and with a specified body weight (90%) on the paretic LE and will simultaneously move a small skateboard forward with the non-paretic LE.

1; 10; 11; 12; 13; 14; 15; 16; 17; 18; 19; 2; 20; 21; 22; 23; 24; 3; 4; 5; 6; 7; 8; 9

Control 4-week exercise intervention OTHER

This intervention occurs in phase 3. Subjects will participate in 1-hour sessions three times per week for four weeks. The control group will perform three sets of ten repetitions of the following 4 exercises, for a total of 120 repetitions: 1) standing hip abduction against green theraband resistance with upper extremity support, 2) sit to stands from chair with no upper extremity support, 3) bilateral calf raises with upper extremity support, and 4) right and left weight shifting exercises using a wobble board with upper extremity support available if needed.

Also known as: conventional physical therapy

1; 10; 11; 12; 2; 3; 4; 5; 6; 7; 8; 9

Experimental 4-week exercise intervention OTHER

This intervention occurs in phase 3. Subjects will participate in 1-hour sessions three times per week for four weeks. The experimental group will perform the skateboard exercise with the optimal parameters established during studies 1 and 2 (that is, an incline angle of either 0 or 5 degrees and a body weight percentage of 50%, 75%, or 90%)--the forward and backward speed of the skateboard will be cued with a metronome that will set at a beats per minute that matches the foot strike cadence of someone walking at 0.7 m/s, and the magnitude of forward excursion of the skateboard will be individualized to the participant based on GAITRite® data (that is, step length of the non-paretic LE).

Also known as: Plantar flexion training

13; 14; 15; 16; 17; 18; 19; 20; 21; 22; 23; 24

Over-ground multi-directional gait training OTHER

In the over-ground multi-directional gait protocol, the participant will walk 750 steps forward, 50 steps backward, and 200 side steps over level surfaces. The over ground gait training will focus on equalizing step length while performing multi-directional gait training.

1; 10; 11; 12; 13; 14; 15; 16; 17; 18; 19; 2; 20; 21; 22; 23; 24; 3; 4; 5; 6; 7; 8; 9

Home exercise OTHER

Home exercise consists of three sets of ten repetitions of the following three exercises to be performed on non-therapy days over the four weeks of phase 3: 1) sit to stands from chair with no upper extremity support, 2) bilateral calf raises with hand support, and 3) resisted side stepping to the non-paretic side using a green theraband with upper extremity support.

1; 10; 11; 12; 13; 14; 15; 16; 17; 18; 19; 2; 20; 21; 22; 23; 24; 3; 4; 5; 6; 7; 8; 9

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be able to perform five times sit to stand test without the use of upper extremities
• Must have 10 degrees of passive ankle dorsiflexion measured in standing
• Must be able to walk with supervision level assistance with no assistive device

You may not qualify if:

• Currently receiving physical therapy
• History of orthopedic ankle instability
• Lacking knee extension to neutral
• Unable to understand English
• Unable to follow multi-step commands
• History of orthopedic pathology that prevents completion of experimental condition
• Pain with weight bearing on paretic LE
• Received Botox to the plantar flexors within the last three months or phenol injections within the last six months
• Walk with a longer nonparetic step length than paretic step length

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Texas Woman's University: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Stroke; Gait Disorders, Neurologic

Interventions

Weights and Measures; Clinical Trials, Phase I as Topic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques; Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Daniel P Wingard, DPT

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical therapist

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: June 7, 2018
• Study Start: October 1, 2018
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-09

Locations

US (1)