StrokeNCT03833544
Lower Limb Flexor Synergy Training in Chronic Stroke
A study testing Exercise training in people with Stroke, run by Methodist Rehabilitation Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2019to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Methodist Rehabilitation Center
Jackson, Mississippi, 39216
About this study
Official title: Effect of Lower Limb Flexor Synergy Training on Motor Function in Chronic Stroke - An Exploratory Study
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.
Read the 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
- Being tested
- Exercise training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
Progressive resistance training of hip, knee, and ankle flexors.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Exercise training: Progressive resistance training of hip, knee, and ankle flexors. Receives: Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
To test if training can alter the lower limb muscle activation profiles during overground walking, surface electromyographic (EMG) signals of different lower extremity muscles during walking will be obtained using a wireless EMG system before and after the training. To test if the changes in profile are maintained after training, a follow-up test will be performed 4 weeks after training finished.
Measured: 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
To test if the training can alter the lower limb muscle activation profiles during obstacle crossing (stepping over a 4x1.5x60 cm^3 wooden block), surface electromyographic (EMG) signals of different lower extremity muscles during obstacle crossing will be obtained using a wireless EMG system before and after the training. To test if the changes in profile are maintained after training, a follow-up test will be performed 4 weeks after training finished.
Measured: 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
In a 6-min walk test, the participant will be asked to walk back and forth around 2 small cones that are 30-m apart as fast as possible for 6 minutes. To test if the training can improve the walk distance in 6 minutes, the distances will be assessed before and after the training. To test if the changes in walk distance are maintained after training, a follow-up test will be performed 4 weeks after training finished.
Measured: 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
To test if the training can improve muscle strength, isometric strength will be assessed in the hip flexors, knee flexors, and ankle dorsiflexors, bilaterally, using a Biodex System 3 dynamometer before and after the training. To test if the changes in muscle strength are maintained after training, a follow-up test will be performed 4 weeks after training finished.
Measured: 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
During a force steadiness test, the participant will be asked to produce a knee flexion torque In the seated position as steady as possible for 10 seconds and match the target torque (10%, 30%, or 50% of maximum torque) displayed on a video monitor. To test if the training can improve the ability to hold a steady force, the force steadiness will be assessed before and after the training. To test if the changes in force steadiness are maintained after training, a follow-up test will be performed 4 weeks after training finished.
Measured: 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 Lower Extremity Motor Function
The lower extremity motor function section of the Fugl-Meyer Assessment (Fugl-Meyer et al., 1975) (FMA-LEM) has a maximum score of 34 points (the higher the score the better the function). To test if the training can improve lower extremity motor function, FMA-LEM scores will be assessed by a licensed therapist before and after the training. To test if the changes in score are maintained after training, a follow-up assessment will be performed 4 weeks after training finished.
Measured: 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 Spasticity
The Modified Ashworth scale (MAS) measures resistance during passive soft-tissue stretching and is a reliable scale for the assessment of spasticity in clinical settings (Bohannon and Smith, 1987). The MAS score ranged from 0 (no increase in muscle tone) to 5 (rigid muscle). To test if the training can improve spasticity, MAS scores of bilateral hip flexors, knee flexors, and ankle dorsiflexors will be assessed by a licensed therapist before and after the training. To test if the changes in score are maintained after training, a follow-up assessment will be performed 4 weeks after training finished.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start3 Jun 2019
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist Rehabilitation Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John W Chow, PhD, Principal investigator, Methodist Rehabiliation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833544
- Sponsor's protocol ID
- MRC_StrFlxTraining
- Status last verified
- May 2023
- First submitted
- 4 Feb 2019
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 3809245Fugl-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.
PubMed 1135616
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lower Limb Flexor Synergy Training on Motor Function in Chronic Stroke - An Exploratory Study
- ClinicalTrials.gov ID
- NCT03833544
- Acronym / sponsor ID
- MRC_StrFlxTraining
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Methodist Rehabilitation CenterUniversity, hospital or other
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 7 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Other: Exercise trainingExercise training: Progressive resistance training of hip, knee, and ankle flexors. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingProgressive resistance training of hip, knee, and ankle flexors. | Other | Treatment Arm |
Primary outcome
Changes in Speed During Overground Gait
Time frame: 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)
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.
Changes in Speed During Obstacle Crossing
Time frame: 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)
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.
Changes in Step Length During Overground Gait
Time frame: 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)
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.
Changes in Step Length During Obstacle Crossing
Time frame: 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)
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.
Changes in Toe Clearance During Overground Gait
Time frame: 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)
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.
Changes in Toe Clearance During Obstacle Crossing
Time frame: 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)
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.
Changes in Peak Knee Flexion Angle in the Swing Phase During Overground Gait
Time frame: 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)
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.
Changes in Peak Knee Flexion Angle in the Swing Phase During Obstacle Crossing
Time frame: 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)
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.
7 secondary outcomes
Changes in Muscle Activation Profiles During Overground Gait
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 Lower Extremity Motor Function
Time frame: 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 Spasticity
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Background: PubMed 3809245Bohannon 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.
- Background: PubMed 1135616Fugl-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John W Chow, PhD principal investigator
Methodist Rehabiliation Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Stroke, run by Methodist Rehabilitation Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Speed During Overground Gait (time frame: 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)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03833544, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.