Immediate Effect of Ankle Mobilization on Active Range of Motion and Gait in Subacute Stroke

NCT06109194 | Completed

• 1 other identifier: 5230164
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to determine the effect of ankle joint mobilization on active range of motion and gait in subacute first-time stroke. The main questions it aims to answer are:

• What is the effect of ankle joint mobilization on active range of motion in the ankle and gait qualities?
• What is the effect of ankle joint mobilization on self-perceived gait ability? Participants will receive physical therapy interventions of:
• Grade III ankle joint mobilization
• stretching of ankle plantarflexor muscles
• ankle muscle activation training
• assisted gait as part of assessment Study design is to measure conditions before and after the intervention to determine effect(s) of one treatment dose, completed within one session of 90 minutes.

Conditions

Hemiparesis;Poststroke/CVA

Keywords

subacute stroke, gait, dorsiflexion, joint mobilization

Outcome Measures

Primary Outcomes (6)

• Active range of motion of the paretic ankle

  ankle (talocrural) joint dorsiflexion movement of the foot away from plantarflexion end-range, measured by goniometry in seated position, by a physical therapist with 25 years' experience. Normal ankle ranges are 0 to 45 degrees from neutral for plantarflexion and 0-25 degrees from neutral for dorsiflexion. 0 to 15 degrees of dorsiflexion is needed for functionally efficient gait. Both passive and active ankle dorsiflexion range of motion are expected to increase, but be less than normal.

  Change between baseline assessment and post-intervention assessment, immediately following intervention

• Gait characteristic of: velocity

  distance and time measurement captured as participant walks over a pressure-sensing mat. Data is processed with ProtoKinetics software. Velocity in meters per second is determined, and compared to normative values for non-stroke males (1.37 m/sec) and females (1.30 m/sec), and in relation to meaningful change in walking speed in in-patient stroke (0.13 m/sec). Velocity is anticipated to increase from pre- to post-intervention, but still be less than normal.

  Change between baseline assessment and post-intervention assessment, immediately following intervention

• Gait characteristic of: stride length

  distance from foot contact to same foot contact measurement in meters captured as participant walks over a pressure-sensing mat. Data is processed with ProtoKinetics software. Findings will be compared to normative values for non-stroke males (1.51m) and females (1.32 m). Distance is hypothesized to increase post-intervention, but not approximate normal distance.

  Change between baseline assessment and post-intervention assessment, immediately following intervention

• Gait characteristic of: second double-limb stance time

  Time measurement of the second occurrence when both feet are in contact with the ground, with reference to the paretic lower extremity. This will be compared to the normative value in adults of 0.12 second, and is hypothesized to be of lower duration post-intervention compared to pre-intervention, but still longer than normal.

  Change between baseline assessment and post-intervention assessment, immediately following intervention

• Gait characteristic of: stride length symmetry

  distance from foot contact to same foot contact measurement in meters captured for each foot as participant walks over a pressure-sensing mat. Data is processed with ProtoKinetics software. Normal gait stride length is symmetrical for adults, and is hypothesized to improve from pre- to post-intervention measurement.

  Change between baseline assessment and post-intervention assessment, immediately following intervention

• Gait characteristic of: second double limb stance symmetry

  Time measurement of the second occurrence when both feet are in contact with the ground. Times with reference to left and right lower extremity will be compared for symmetry. It is hypothesized that second double limb stance time will improve toward symmetry from pre- to post-intervention measurement.

  Change between baseline assessment and post-intervention assessment, immediately following intervention

Secondary Outcomes (1)

• Subjective rating of perceived ability to walk

  Change between baseline assessment and post-intervention assessment, immediately following intervention

Study Arms (1)

Intervention

EXPERIMENTAL

Pre-assessment of active and passive range of motion in the paretic ankle, and five strides of gait assessment on a pressure-sensitive mat. Intervention will be moderate grade III anterior-to-posterior directed ankle mobilization for 2 minutes while supine, ankle muscle stretch for 75 seconds in standing, ankle muscle training for 3 minutes while seated. Post-assessment is repeated in the same sequence and content as pre-assessment.

Other: Joint mobilization

Interventions

Joint mobilization OTHER

Grade III manual joint mobilization as standard-of-care physical therapy intervention

Also known as: manual therapy, tissue stretch

Intervention

Eligibility Criteria

• Age: 21 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First stroke
• subacute phase after stroke
• able to follow one-step commands
• paretic passive ankle dorsiflexion less than 5 degrees

You may not qualify if:

• ankle pain of undetermined cause at rest
• fracture in paretic lower extremity
• muscle or ligament tear
• recent ankle sprain
• skin tear or wound
• joint fusion or implanted hardware

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Health

Loma Linda, California, 92350, United States

Location

Related Publications (12)

• Kim SL, Lee BH. The Effects of Posterior Talar Glide and Dorsiflexion of the Ankle Plus Mobilization with Movement on Balance and Gait Function in Patient with Chronic Stroke: A Randomized Controlled Trial. J Neurosci Rural Pract. 2018 Jan-Mar;9(1):61-67. doi: 10.4103/jnrp.jnrp_382_17.

  PMID: 29456346 BACKGROUND

• An CM, Jo SO. Effects of Talocrural Mobilization with Movement on Ankle Strength, Mobility, and Weight-Bearing Ability in Hemiplegic Patients with Chronic Stroke: A Randomized Controlled Trial. J Stroke Cerebrovasc Dis. 2017 Jan;26(1):169-176. doi: 10.1016/j.jstrokecerebrovasdis.2016.09.005. Epub 2016 Oct 17.

  PMID: 27765557 BACKGROUND

• An CM, Won JI. Effects of ankle joint mobilization with movement and weight-bearing exercise on knee strength, ankle range of motion, and gait velocity in patients with stroke: a pilot study. J Phys Ther Sci. 2016 Jan;28(2):689-94. doi: 10.1589/jpts.28.689. Epub 2016 Feb 29.

  PMID: 27065565 BACKGROUND

• Alamer A, Melese H, Getie K, Deme S, Tsega M, Ayhualem S, Birhanie G, Abich Y, Yitayeh Gelaw A. Effect of Ankle Joint Mobilization with Movement on Range of Motion, Balance and Gait Function in Chronic Stroke Survivors: Systematic Review of Randomized Controlled Trials. Degener Neurol Neuromuscul Dis. 2021 Sep 1;11:51-60. doi: 10.2147/DNND.S317865. eCollection 2021.

  PMID: 34512072 BACKGROUND

• Cho KH, Park SJ. Effects of joint mobilization and stretching on the range of motion for ankle joint and spatiotemporal gait variables in stroke patients. J Stroke Cerebrovasc Dis. 2020 Aug;29(8):104933. doi: 10.1016/j.jstrokecerebrovasdis.2020.104933. Epub 2020 Jun 8.

  PMID: 32689617 BACKGROUND

• Kang MH, Oh JS, Kwon OY, Weon JH, An DH, Yoo WG. Immediate combined effect of gastrocnemius stretching and sustained talocrural joint mobilization in individuals with limited ankle dorsiflexion: A randomized controlled trial. Man Ther. 2015 Dec;20(6):827-34. doi: 10.1016/j.math.2015.03.016. Epub 2015 Apr 2.

  PMID: 25907146 BACKGROUND

• Gao F, Ren Y, Roth EJ, Harvey R, Zhang LQ. Effects of repeated ankle stretching on calf muscle-tendon and ankle biomechanical properties in stroke survivors. Clin Biomech (Bristol). 2011 Jun;26(5):516-22. doi: 10.1016/j.clinbiomech.2010.12.003. Epub 2011 Jan 6.

  PMID: 21211873 BACKGROUND

• Forghany S, Nester CJ, Tyson SF, Preece S, Jones RK. The effect of stroke on foot kinematics and the functional consequences. Gait Posture. 2014 Apr;39(4):1051-6. doi: 10.1016/j.gaitpost.2014.01.006. Epub 2014 Jan 31.

  PMID: 24548798 BACKGROUND

• Mirbagheri MM, Alibiglou L, Thajchayapong M, Rymer WZ. Muscle and reflex changes with varying joint angle in hemiparetic stroke. J Neuroeng Rehabil. 2008 Feb 27;5:6. doi: 10.1186/1743-0003-5-6.

  PMID: 18304313 BACKGROUND

• Shorter AL, Richardson JK, Finucane SB, Joshi V, Gordon K, Rouse EJ. Characterization and clinical implications of ankle impedance during walking in chronic stroke. Sci Rep. 2021 Aug 18;11(1):16726. doi: 10.1038/s41598-021-95737-6.

  PMID: 34408174 BACKGROUND

• Forrester LW, Wheaton LA, Luft AR. Exercise-mediated locomotor recovery and lower-limb neuroplasticity after stroke. J Rehabil Res Dev. 2008;45(2):205-20. doi: 10.1682/jrrd.2007.02.0034.

  PMID: 18566939 BACKGROUND

• Simpson DB, Breslin M, Cumming T, de Zoete SA, Gall SL, Schmidt M, English C, Callisaya ML. Sedentary time and activity behaviors after stroke rehabilitation: Changes in the first 3 months home. Top Stroke Rehabil. 2021 Jan;28(1):42-51. doi: 10.1080/10749357.2020.1783917. Epub 2020 Jun 24.

  PMID: 32578523 BACKGROUND

MeSH Terms

Interventions

Musculoskeletal Manipulations

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Eric G Johnson, PT, DSc

  Loma Linda University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking to occur
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: pre-test, intervention, post-test

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: December 19, 2023
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: January 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)