Lower Limb Flexor Synergy Training in Chronic Stroke

NCT ID: NCT03833544

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-03
• Study Completion Date: 2022-11-01

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.

Detailed Description

It is known that the muscles that flex the hip, knee, and ankle joints are responsible for bringing the leg up and forward during walking and for a successful recovery from a slip or trip. Many previous studies have focused on strengthening the lower limb muscles that support the body in standing and walking (the so-called anti-gravity extensor muscles) but the training targeting the lower limb flexors has rarely been emphasized in stroke rehabilitation. Therefore, it is the intent of this exploratory study to find out whether an exercise training program focusing on lower limb flexors can improve lower limb motor function late after stroke.

Ten participants with chronic stroke will be recruited. Their lower limb muscle function and walking performance will be assessed at baseline (2 to 3 times within the 2 weeks prior to starting the training), at the end of training, and 4 weeks later.

Each subject will perform biking exercises under supervision, 2-3 times per week for 4 weeks (30 minutes each). The bike pedals are moving backward at a preset speed regardless of user effort. With feet strapped to the pedals, the participant will be asked to activate the hip, knee, and ankle flexors simultaneously when the pedal is moving up and then relax. Heart rate (HR) will be monitored continuously using a fingertip pulse monitor to ensure the maximum training HR is no more than 75% of the subject's HR Reserve.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

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

Group Type: EXPERIMENTAL

Exercise training

Intervention Type: OTHER

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

Interventions

Exercise training

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Methodist Rehabilitation Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John W Chow, PhD

Role: PRINCIPAL_INVESTIGATOR

Methodist Rehabiliation Center

Locations

Methodist Rehabilitation Center

Jackson, Mississippi, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 3809245 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 1135616 (View on PubMed)

Other Identifiers

MRC_StrFlxTraining

Identifier Type: -

Identifier Source: org_study_id