Lower Limb Flexor Synergy Training in Chronic Stroke

NCT03833544 | Completed DMC

• 1 other identifier: MRC_StrFlxTraining
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates whether a 4-week exercise training program focusing on lower limb flexors can improve lower limb motor function late after stroke. It is hypothesized that there would be significant improvements in gait and strength of the flexor muscles as a result of the training. It is also hypothesized that the training effects, if any, would be retained at 4 weeks after ending the training.

Conditions

Stroke

Outcome Measures

Primary Outcomes (8)

• Changes in Speed During Overground Gait

  To test if the training can improve gait speed during overground walking, gait speeds will be obtained using a video-based 3D motion capture system before and after the training. To test if the gait speed changes are maintained after training, a follow-up test will be performed 4 weeks after training finished.

  Weeks 1-2: Baseline Assessment (2-3 times); Weeks 3-6: Training (no assessment); Week 7: Post-training Assessment (within 1 week after the end of training); Week 10: Follow-up Assessment (4 weeks after the end of training)

• Changes in Speed During Obstacle Crossing

  To test if the training can improve the speed during obstacle crossing (stepping over a 4x1.5x60 cm\^3 wooden block), speeds during obstacle crossing will be obtained using a video-based 3D motion capture system before and after the training. To test if the speed changes are maintained after training, a follow-up test will be performed 4 weeks after training finished.

  Weeks 1-2: Baseline Assessment (2-3 times); Weeks 3-6: Training (no assessment); Week 7: Post-training Assessment (within 1 week after the end of training); Week 10: Follow-up Assessment (4 weeks after the end of training)

• Changes in Step Length During Overground Gait

  To test if the training can improve the step length during overground walking, step lengths will be obtained using a video-based 3D motion capture system before and after the training. To test if the step length changes are maintained after training, a follow-up test will be performed 4 weeks after training finished.

  Weeks 1-2: Baseline Assessment (2-3 times); Weeks 3-6: Training (no assessment); Week 7: Post-training Assessment (within 1 week after the end of training); Week 10: Follow-up Assessment (4 weeks after the end of training)

• Changes in Step Length During Obstacle Crossing

  To test if training can improve the step length during obstacle crossing (stepping over a 4x1.5x60 cm\^3 wooden block), step lengths during obstacle crossing will be obtained using a video-based 3D motion capture system before and after the training. To test if the step length changes are maintained after training, a follow-up test will be performed 4 weeks after training finished.

  Weeks 1-2: Baseline Assessment (2-3 times); Weeks 3-6: Training (no assessment); Week 7: Post-training Assessment (within 1 week after the end of training); Week 10: Follow-up Assessment (4 weeks after the end of training)

• Changes in Toe Clearance During Overground Gait

  To test if the training can improve toe clearance during overground walking, toe clearances will be obtained using a video-based 3D motion capture system before and after the training. To test if the toe clearance changes are maintained after training, a follow-up test will be performed 4 weeks after training finished.

  Weeks 1-2: Baseline Assessment (2-3 times); Weeks 3-6: Training (no assessment); Week 7: Post-training Assessment (within 1 week after the end of training); Week 10: Follow-up Assessment (4 weeks after the end of training)

• Changes in Toe Clearance During Obstacle Crossing

  To test if the training can improve the toe clearance during obstacle crossing (stepping over a 4x1.5x60 cm\^3 wooden block), toe clearances during obstacle crossing will be obtained using a video-based 3D motion capture system before and after the training. To test if the toe clearance changes are maintained after training, a follow-up test will be performed 4 weeks after training finished.

  Weeks 1-2: Baseline Assessment (2-3 times); Weeks 3-6: Training (no assessment); Week 7: Post-training Assessment (within 1 week after the end of training); Week 10: Follow-up Assessment (4 weeks after the end of training)

• Changes in Peak Knee Flexion Angle in the Swing Phase During Overground Gait

  To test if training can improve the peak knee flexion angle in the swing phase during overground walking, knee flexion angles will be obtained using a video-based 3D motion capture system before and after the training. To test if the angle changes are maintained after training, a follow-up test will be performed 4 weeks after training finished.

  Weeks 1-2: Baseline Assessment (2-3 times); Weeks 3-6: Training (no assessment); Week 7: Post-training Assessment (within 1 week after the end of training); Week 10: Follow-up Assessment (4 weeks after the end of training)

• Changes in Peak Knee Flexion Angle in the Swing Phase During Obstacle Crossing

  To test if the training can improve the peak knee flexion angle in the swing phase during obstacle crossing (stepping over a 4x1.5x60 cm\^3 wooden block), knee flexion angles will be obtained using a video-based 3D motion capture system before and after the training. To test if the angle changes are maintained after training, a follow-up test will be performed 4 weeks after training finished.

  Weeks 1-2: Baseline Assessment (2-3 times); Weeks 3-6: Training (no assessment); Week 7: Post-training Assessment (within 1 week after the end of training); Week 10: Follow-up Assessment (4 weeks after the end of training)

Secondary Outcomes (7)

• Changes in Muscle Activation Profiles During Overground Gait

  Weeks 1-2: Baseline Assessment (2-3 times); Weeks 3-6: Training (no assessment); Week 7: Post-training Assessment (within 1 week after the end of training); Week 10: Follow-up Assessment (4 weeks after the end of training)

• Changes in Muscle Activation Profiles During Obstacle Crossing

  Weeks 1-2: Baseline Assessment (2-3 times); Weeks 3-6: Training (no assessment); Week 7: Post-training Assessment (within 1 week after the end of training); Week 10: Follow-up Assessment (4 weeks after the end of training)

• Changes in 6-min Walk Distance

  Weeks 1-2: Baseline Assessment (2-3 times); Weeks 3-6: Training (no assessment); Week 7: Post-training Assessment (within 1 week after the end of training); Week 10: Follow-up Assessment (4 weeks after the end of training)

• Changes in Muscle Strength

  Weeks 1-2: Baseline Assessment (2-3 times); Weeks 3-6: Training (no assessment); Week 7: Post-training Assessment (within 1 week after the end of training); Week 10: Follow-up Assessment (4 weeks after the end of training)

• Changes in Force Steadiness

  Weeks 1-2: Baseline Assessment (2-3 times); Weeks 3-6: Training (no assessment); Week 7: Post-training Assessment (within 1 week after the end of training); Week 10: Follow-up Assessment (4 weeks after the end of training)

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Exercise training: Progressive resistance training of hip, knee, and ankle flexors.

Other: Exercise training

Interventions

Exercise training OTHER

Progressive resistance training of hip, knee, and ankle flexors.

Treatment Arm

Eligibility Criteria

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

You may qualify if:

• Time post-stroke between 6 months and 3 years
• Able to walk with or without an assistive device for 7 m independently
• Abnormal flexor synergy in both hip and knee joints (score 1 or 2) on the Fugl-Meyer Assessment Lower Extremity section II: Volitional movement within synergies (Fugl-Meyer et al., 1975)
• Walk slower than 1 m/s
• Able to understand and follow simple instructions
• Agree not to participate in strength training or supervised physical therapy during and for at least 4 weeks after the completion of training
• Previous participation in the physical therapy program for stroke without experiencing excessive symptoms (shortness of breath, headache, prolonged fatigue)

You may not qualify if:

• Current symptomatic coronary artery disease or congestive heart failure
• History of myocardial infarction
• Uncontrolled hypertension (\>150/90 mm Hg)
• Lower limb fracture in the past 6 months
• Lower limb joint or muscular problems
• Acute or terminal illness
• Current participation in strength training or supervised physical therapy

Sponsors & Collaborators

• Methodist Rehabilitation Center: lead

Study Sites (1)

Methodist Rehabilitation Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (2)

• Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.

  PMID: 3809245 BACKGROUND

• Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.

  PMID: 1135616 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• John W Chow, PhD

  Methodist Rehabiliation Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 7, 2019
• Study Start: June 3, 2019
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: May 8, 2025

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)