StrokeNCT05953272
A Clinical Trial to Study the Effects of Bobath Therapy With and Without EMG Biofeedback Therapy in Stroke Patients
A study testing EMG Biofeedback therapy and Bobath therapy and Bobath therapy in people with Stroke, run by National Institute for Locomotor Disabilities (Divyangjan), India at 1 site in India.
Trial summary
Stroke is a leading cause of disability worldwide. It has a negative impact on the cognitive and sensorimotor functions. Motor recovery becomes essential in rehabilitation phase to make the patient independent in activities of daily living along with improved lower extremity function, balance and gait. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- EMG Biofeedback therapy and Bobath therapy and Bobath therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 1 May 2023to 30 Apr 2024
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both male and female patients aged between 40 - 65 years.
- Patients with first attack of stroke, diagnosed by a physician.
- Duration of stroke 3 months to 3 years.
- Patient has no cognitive impairment and has a MMSE Score ≥ 24.
- Grade of spasticity upto 2 in lower extremity on Modified Ashworth Scale.
- Patient is in Brunnstrom lower limb recovery stage 3 and 4.
Show all 9Show fewer
- Patient should have passive 10° or greater ankle dorsiflexion.
- Patient can sit independently on a plinth.
- Patient should be ambulatory either independently or with some assistive aid.
Who cannot join
- Patient with any sensory deficit of the lower extremity.
- Problems with vision, like - homonymous hemianopsia, hemiagnosia, visual agnosia etc.
- Patients with hearing loss.
- Patients with hemineglect.
- Patients with sensory, conduction or global aphasia.
- Musculoskeletal conditions like - fracture, contracture and deformity in lower extremity.
- Diagnosed neurological diseases like - Parkinsonism, Dementia, Peripheral nerve injury in the lower extremity etc.
- Diagnosed systemic diseases like - uncontrolled hypertension etc. and/or peripheral vascular disease in lower extremity like - Raynaud's disease etc.
Trial locations and contacts
1 site in 1 country.
India1 site
National Institute for Locomotor Disabilities (Divyangjan)
Kolkata, West Bengal, 700090
About this study
Official title: Comparative Efficacy of EMG Biofeedback Therapy Along With Bobath Therapy and Bobath Therapy Alone on Lower Extremity Functions, Balance and Gait in Patients With Stroke: a Randomized Clinical Trial
Stroke is a leading cause of disability worldwide. It has a negative impact on the cognitive and sensorimotor functions. Motor recovery becomes essential in rehabilitation phase to make the patient independent in activities of daily living along with improved lower extremity function, balance and gait. Studies show that both EMG Biofeedback therapy and Bobath therapy is effective in improving lower extremity function. Out of those studies, to the best of the investigators knowledge, no study has been conducted to find out the efficacy of EMG Biofeedback therapy along with Bobath therapy on lower extremity functions, balance and gait in stroke patients. Therefore the purpose of the study is to find out the comparative efficacy of EMG Biofeedback therapy along with Bobath therapy and Bobath therapy alone on lower extremity functions, balance and gait in patients with stroke.
Read the detailed description
Purpose of the Study:
There are studies available in which EMG Biofeedback therapy significantly improves lower extremity functions. Bobath therapy has also shown significant effect in recovery of lower extremity functions after stroke. Out of those studies, to the best of the investigators knowledge, no study has been conducted to find the comparative efficacy of EMG Biofeedback therapy along with Bobath therapy and Bobath therapy alone on lower extremity functions, balance and gait in Indian population with stroke patients.
Therefore, the purpose of the study is to find out the comparative efficacy of EMG Biofeedback therapy along with Bobath therapy and Bobath therapy alone on lower extremity functions, balance and gait in patients with stroke.
Aim and Objectives:
Aim:
To find out the comparative efficacy of EMG Biofeedback therapy along with Bobath therapy and Bobath therapy alone on lower extremity functions, balance and gait in patients with stroke.
Objectives:
- To find out the efficacy of EMG Biofeedback therapy along with Bobath therapy on lower extremity functions, balance and gait in patients with stroke.
- To find out the efficacy of Bobath therapy on lower extremity functions, balance and gait in patients with stroke.
- To compare the efficacy of EMG Biofeedback therapy along with Bobath therapy and Bobath therapy alone on lower extremity functions, balance and gait in patients with stroke.
Hypotheses:
Null Hypothesis:
There is no statistically significant difference between the efficacy of EMG Biofeedback therapy along with Bobath therapy and Bobath therapy alone on lower extremity functions, balance and gait in patients with stroke.
Alternative Hypothesis:
There is statistically significant difference between the efficacy of EMG Biofeedback therapy along with Bobath therapy and Bobath therapy alone on lower extremity functions, balance and gait in patients with stroke.
Study Variables:
Independent Variables:
- EMG Biofeedback therapy
- Bobath therapy
Dependent Variables:
- Lower extremity function will be measured by - Lower Extremity Subscale of Fugl Meyer Assessment [FMA].
- Balance will be measured by -Timed Up and Go [TUG] Test.
- Gait will be measured by - 10-meter Walk Test [10mWT].
Procedure:
Approval from the Institutional Ethical Committee (IEC) will be taken before commencement of the study. All patients diagnosed with hemiplegic stroke referred from Assessment Clinic of NILD to the Department of Physiotherapy will be approached with the study proposal. Minimum of 30 patients with hemiplegic stroke will be included after proper assessment and screening according to the inclusion and exclusion criteria. Those fulfilling the inclusion criteria will be explained in details about the study in their most communicable language. Written informed consent in their preferred language will be obtained from the patients agreeing to participate. The patients will be randomly divided into two groups using block randomization method by computer generated random blocks. The demographic data and the outcome measures data will be collected from each patient for lower extremity function by Lower Extremity Subscale of Fugl Meyer Assessment [FMA], balance by Timed Up and Go Test [TUG] and gait by 10-meter Walk Test [10mWT] at baseline and at the end of four weeks of intervention. In Group-A (n≥15) EMG Biofeedback therapy and Bobath therapy will be given for 16 sessions (4 sessions per week for 4 weeks). In Group- B (n≥15) only Bobath therapy will be given for 16 sessions (4 sessions per week for 4 weeks). Home exercise program will be given in both groups.
Rescue medications duly prescribed by physician will be continued along with the physiotherapeutic approach in both the groups during the study.
- Conditions
- Stroke
- Being tested
- EMG Biofeedback therapy and Bobath therapy, Bobath therapy
- Keywords
- Stroke, CVA, Bobath therapy, EMG Biofeedback therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMG Biofeedback therapy and Bobath therapyOther
EMG Biofeedback therapy will be used to up-train the ankle dorsiflexors in stroke patients. It will be given for 15 minutes. Patient will practice 2 blocks of Tibialis Anterior muscle contraction trials (holding for 10 seconds per trial with 10 seconds of rest, 20 trials per block with 1 minute 40 seconds of rest in between the blocks) with the heel contacts the floor for a total of 40 trials.
In Bobath therapy, we will use exercises as per Bobath guidelines for management of stroke patients to improve the lower extremity function, balance and gait ability. All of the exercises will be performed for 10 repetitions in each session.
Patient will also perform a set of Home Exercise Program given to them for once daily in their home during the treatment period.
Bobath therapyOther
In Bobath therapy, we will use exercises as per Bobath guidelines for management of stroke patients to improve the lower extremity function, balance and gait ability. All of the exercises will be performed for 10 repetitions in each session.
Patient will also perform a set of Home Exercise Program given to them for once daily in their home during the treatment period.
| Study group | Role | What they receive |
|---|---|---|
| EMG Biofeedback therapy and Bobath therapy | Experimental | The experimental group will receive EMG Biofeedback therapy for 15 minutes along with Bobath therapy for 45 minutes and home exercise program. The EMG Biofeedback therapy and Bobath therapy will be given for 16 sessions (4 sessions per week for 4 weeks). Patient will perform the home exercise program once a day in home during 4 weeks of treatment period. Receives: Other: EMG Biofeedback therapy and Bobath therapy |
| Bobath therapy only | Active comparator | This group will receive only Bobath therapy for 45 minutes and home exercise program. The Bobath therapy will be given for 16 sessions (4 sessions per week for 4 weeks). Patient will perform the home exercise program once a day in home during 4 weeks of treatment period. Receives: Other: Bobath therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Lower Extremity Subscale of Fugl Meyer Assessment [FMA] at 4 weeks
Lower extremity function and motor recovery will be measured by the Lower Extremity Subscale of Fugl Meyer Assessment [FMA]. It is a simple, reliable and valid scale. It has 2 parts - E. Lower Extremity and F. Co-ordination Speed. Scoring of both the parts combined will determine the motor function of lower limb. In (E) Lower Extremity, it has 5 sub-parts: Reflex activity, Volitional movement within synergies, Volitional movement mixing synergies, Volitional movement with little or no synergy and Normal Reflex activity which has a maximum score of 4, 14, 4, 4, 2; i.e., a maximum total score of 28. The (F) Coordination and Speed has 3 parts to check - Tremor, Dysmetria and Time which has a maximum score of 2, 2 and 2; i.e., maximum total score of 6. The Total Maximum Score for measuring Lower Extremity Motor Function is 34.
Patient will be demonstrated about the scale beforehand.
Measured: Baseline, Week 4
Change from Baseline Timed Up and Go Test [TUG] at 4 weeks
TUG Test is a reliable and valid scale which is used to assess balance and mobility. In this test, the patient will stand up from a standard arm chair with his/her regular footwear, walk to the line 3 meters away from him on the floor at his/her normal pace and he/she turns, walk back to the chair again at normal pace to sit down again. The patient can use a walking aid, if needed. The therapist will use a stopwatch to measure the time needed by the patient to do all the activity.
Patient will be demonstrated about the scale beforehand.
Measured: Baseline, Week 4
Change from Baseline 10-meter Walk Test [10mWT] at 4 weeks
In, 10-Meter Walk Test, an individual walks for 14 meters and time will be measured for the intermediate 10 meters to allow for acceleration and deceleration respectively.
The therapist will start the timing when the toes of leading foot cross the 2-meter mark and stops timing when the toes of the leading foot cross the 12-meter mark.
This test will be performed at Comfortable Gait Speed [CGS] and also the Fast Gait Speed [FGS] possible. There will be three trials for each speed with a 30 seconds break in between. The mean of the 3 readings will be taken as final outcome. Both of the speeds will be documented in the form.
It is a reliable and valid scale.
Patient will be demonstrated about the scale beforehand.
Measured: Baseline, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start1 May 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, parallel group, active controlled trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute for Locomotor Disabilities (Divyangjan), India
- Sponsor type
- Other government
- Responsible party
- Principal investigator, SANLAP KUNDU, National Institute for Locomotor Disabilities (Divyangjan), India
- Investigators
- Sanlap Kundu, BPT, Principal investigator, The West Bengal University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953272
- Sponsor's protocol ID
- IEC/1610/R&D/08/NIOH/20328
- Other IDs
- CTRI/2023/04/051999
- Status last verified
- May 2025
- First submitted
- 1 Jul 2023
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of EMG Biofeedback Therapy Along With Bobath Therapy and Bobath Therapy Alone on Lower Extremity Functions, Balance and Gait in Patients With Stroke: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05953272
- Acronym / sponsor ID
- IEC/1610/R&D/08/NIOH/20328
- Conditions
- Stroke
- Keywords
- Stroke, CVA, Bobath therapy, EMG Biofeedback therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Institute for Locomotor Disabilities (Divyangjan), IndiaOther government
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 20 Jul 2023 (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.
Stroke is a leading cause of disability worldwide. It has a negative impact on the cognitive and sensorimotor functions. Motor recovery becomes essential in rehabilitation phase to make the patient independent in activities of daily living along with improved lower extremity function, balance and gait. Studies show that both EMG Biofeedback therapy and Bobath therapy is effective in improving lower extremity function. Out of those studies, to the best of the investigators knowledge, no study has been conducted to find out the efficacy of EMG Biofeedback therapy along with Bobath therapy on lower extremity functions, balance and gait in stroke patients. Therefore the purpose of the study is to find out the comparative efficacy of EMG Biofeedback therapy along with Bobath therapy and Bobath therapy alone on lower extremity functions, balance and gait in patients with stroke.
Detailed description
Purpose of the Study:
There are studies available in which EMG Biofeedback therapy significantly improves lower extremity functions. Bobath therapy has also shown significant effect in recovery of lower extremity functions after stroke. Out of those studies, to the best of the investigators knowledge, no study has been conducted to find the comparative efficacy of EMG Biofeedback therapy along with Bobath therapy and Bobath therapy alone on lower extremity functions, balance and gait in Indian population with stroke patients.
Therefore, the purpose of the study is to find out the comparative efficacy of EMG Biofeedback therapy along with Bobath therapy and Bobath therapy alone on lower extremity functions, balance and gait in patients with stroke.
Aim and Objectives:
Aim:
To find out the comparative efficacy of EMG Biofeedback therapy along with Bobath therapy and Bobath therapy alone on lower extremity functions, balance and gait in patients with stroke.
Objectives:
- To find out the efficacy of EMG Biofeedback therapy along with Bobath therapy on lower extremity functions, balance and gait in patients with stroke.
- To find out the efficacy of Bobath therapy on lower extremity functions, balance and gait in patients with stroke.
- To compare the efficacy of EMG Biofeedback therapy along with Bobath therapy and Bobath therapy alone on lower extremity functions, balance and gait in patients with stroke.
Hypotheses:
Null Hypothesis:
There is no statistically significant difference between the efficacy of EMG Biofeedback therapy along with Bobath therapy and Bobath therapy alone on lower extremity functions, balance and gait in patients with stroke.
Alternative Hypothesis:
There is statistically significant difference between the efficacy of EMG Biofeedback therapy along with Bobath therapy and Bobath therapy alone on lower extremity functions, balance and gait in patients with stroke.
Study Variables:
Independent Variables:
- EMG Biofeedback therapy
- Bobath therapy
Dependent Variables:
- Lower extremity function will be measured by - Lower Extremity Subscale of Fugl Meyer Assessment [FMA].
- Balance will be measured by -Timed Up and Go [TUG] Test.
- Gait will be measured by - 10-meter Walk Test [10mWT].
Procedure:
Approval from the Institutional Ethical Committee (IEC) will be taken before commencement of the study. All patients diagnosed with hemiplegic stroke referred from Assessment Clinic of NILD to the Department of Physiotherapy will be approached with the study proposal. Minimum of 30 patients with hemiplegic stroke will be included after proper assessment and screening according to the inclusion and exclusion criteria. Those fulfilling the inclusion criteria will be explained in details about the study in their most communicable language. Written informed consent in their preferred language will be obtained from the patients agreeing to participate. The patients will be randomly divided into two groups using block randomization method by computer generated random blocks. The demographic data and the outcome measures data will be collected from each patient for lower extremity function by Lower Extremity Subscale of Fugl Meyer Assessment [FMA], balance by Timed Up and Go Test [TUG] and gait by 10-meter Walk Test [10mWT] at baseline and at the end of four weeks of intervention. In Group-A (n≥15) EMG Biofeedback therapy and Bobath therapy will be given for 16 sessions (4 sessions per week for 4 weeks). In Group- B (n≥15) only Bobath therapy will be given for 16 sessions (4 sessions per week for 4 weeks). Home exercise program will be given in both groups.
Rescue medications duly prescribed by physician will be continued along with the physiotherapeutic approach in both the groups during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a randomized, parallel group, active controlled trial.
| Arm | Type | Receives |
|---|---|---|
| EMG Biofeedback therapy and Bobath therapy | Experimental | Other: EMG Biofeedback therapy and Bobath therapyThe experimental group will receive EMG Biofeedback therapy for 15 minutes along with Bobath therapy for 45 minutes and home exercise program. The EMG Biofeedback therapy and Bobath therapy will be given for 16 sessions (4 sessions per week for 4 weeks). Patient will perform the home exercise program once a day in home during 4 weeks of treatment period. |
| Bobath therapy only | Active comparator | Other: Bobath therapyThis group will receive only Bobath therapy for 45 minutes and home exercise program. The Bobath therapy will be given for 16 sessions (4 sessions per week for 4 weeks). Patient will perform the home exercise program once a day in home during 4 weeks of treatment period. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Both male and female patients aged between 40 - 65 years.
- Patients with first attack of stroke, diagnosed by a physician.
- Duration of stroke 3 months to 3 years.
- Patient has no cognitive impairment and has a MMSE Score ≥ 24.
- Grade of spasticity upto 2 in lower extremity on Modified Ashworth Scale.
Key exclusion criteria (8 listed)
- Patient with any sensory deficit of the lower extremity.
- Problems with vision, like - homonymous hemianopsia, hemiagnosia, visual agnosia etc.
- Patients with hearing loss.
- Patients with hemineglect.
- Patients with sensory, conduction or global aphasia.
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 |
|---|---|---|
| EMG Biofeedback therapy and Bobath therapyEMG Biofeedback therapy will be used to up-train the ankle dorsiflexors in stroke patients. It will be given for 15 minutes. Patient will practice 2 blocks of Tibialis Anterior muscle contraction trials (holding for 10 seconds per trial with 10 seconds of rest, 20 trials per block with 1 minute 40 seconds of rest in between the blocks) with the heel contacts the floor for a total of 40 trials. In Bobath therapy, we will use exercises as per Bobath guidelines for management of stroke patients to improve the lower extremity function, balance and gait ability. All of the exercises will be performed for 10 repetitions in each session. Patient will also perform a set of Home Exercise Program given to them for once daily in their home during the treatment period. | Other | EMG Biofeedback therapy and Bobath therapy |
| Bobath therapyIn Bobath therapy, we will use exercises as per Bobath guidelines for management of stroke patients to improve the lower extremity function, balance and gait ability. All of the exercises will be performed for 10 repetitions in each session. Patient will also perform a set of Home Exercise Program given to them for once daily in their home during the treatment period. | Other | Bobath therapy only |
Primary outcome
Change from Baseline Lower Extremity Subscale of Fugl Meyer Assessment [FMA] at 4 weeks
Time frame: Baseline, Week 4
Lower extremity function and motor recovery will be measured by the Lower Extremity Subscale of Fugl Meyer Assessment [FMA]. It is a simple, reliable and valid scale. It has 2 parts - E. Lower Extremity and F. Co-ordination Speed. Scoring of both the parts combined will determine the motor function of lower limb. In (E) Lower Extremity, it has 5 sub-parts: Reflex activity, Volitional movement within synergies, Volitional movement mixing synergies, Volitional movement with little or no synergy and Normal Reflex activity which has a maximum score of 4, 14, 4, 4, 2; i.e., a maximum total score of 28. The (F) Coordination and Speed has 3 parts to check - Tremor, Dysmetria and Time which has a maximum score of 2, 2 and 2; i.e., maximum total score of 6. The Total Maximum Score for measuring Lower Extremity Motor Function is 34. Patient will be demonstrated about the scale beforehand.
Change from Baseline Timed Up and Go Test [TUG] at 4 weeks
Time frame: Baseline, Week 4
TUG Test is a reliable and valid scale which is used to assess balance and mobility. In this test, the patient will stand up from a standard arm chair with his/her regular footwear, walk to the line 3 meters away from him on the floor at his/her normal pace and he/she turns, walk back to the chair again at normal pace to sit down again. The patient can use a walking aid, if needed. The therapist will use a stopwatch to measure the time needed by the patient to do all the activity. Patient will be demonstrated about the scale beforehand.
Change from Baseline 10-meter Walk Test [10mWT] at 4 weeks
Time frame: Baseline, Week 4
In, 10-Meter Walk Test, an individual walks for 14 meters and time will be measured for the intermediate 10 meters to allow for acceleration and deceleration respectively. The therapist will start the timing when the toes of leading foot cross the 2-meter mark and stops timing when the toes of the leading foot cross the 12-meter mark. This test will be performed at Comfortable Gait Speed [CGS] and also the Fast Gait Speed [FGS] possible. There will be three trials for each speed with a 30 seconds break in between. The mean of the 3 readings will be taken as final outcome. Both of the speeds will be documented in the form. It is a reliable and valid scale. Patient will be demonstrated about the scale beforehand.
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 22 May 2025.
- Individual participant dataSharing planned: No
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Sanlap Kundu, BPT principal investigator
The West Bengal University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EMG Biofeedback therapy and Bobath therapy and Bobath therapy in people with Stroke, run by National Institute for Locomotor Disabilities (Divyangjan), India at 1 site in India.
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 9 inclusion and 8 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 22 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 India. 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?
Change from Baseline Lower Extremity Subscale of Fugl Meyer Assessment [FMA] at 4 weeks (time frame: Baseline, Week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2025.