StrokeCIMT-MRPNCT06806553
Constraint-Induced Movement Therapy (CIMT) with Motor Relearning Program (MRP) and Bobath Approach to Augment Functional Motor Recovery of Chronic Hemiparetic Arm
A study testing Constraint-Induced Movement Therapy (CIMT) With Motor Relearning Program (MRP) and Bobath Therapy in people with Stroke and Hemiparesis, run by University of Lahore at 1 site in Pakistan.
Trial summary
Hemiparesis is a condition characterized by weakness or the inability to move on one side of the body, making it difficult to perform everyday activities like eating or dressing (Iswatun et al., 2022). Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Stroke, Hemiparesis, Hemiparesis After Stroke
- What is being tested?
- Constraint-Induced Movement Therapy (CIMT) With Motor Relearning Program (MRP) and Bobath Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 26 Jan 2024to 21 Dec 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 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with chronic hemiparesis at least 6 months prior to study enrollment (Lang et al., 2016).
- Chronic hemiparesis affecting one arm only (Lang et al., 2016).
- Age between 50 and 65 years old (Lang et al., 2016).
- Patients experiencing functional limitations in upper limb motor function (Gracies et al., 2019).
- Mini-Mental State Examination (MMSE) score ≥ 24 (Page et al., 2007).
- Patients with mild to moderate spasticity (Jan et al., 2019).
- Able to tolerate and participate actively in the assigned intervention (Gracies et al., 2019)
Who cannot join
- Recent acute medical/surgical condition unrelated to stroke (Lang et al., 2016).
- Severe cognitive impairment or communication difficulties (Lang et al., 2016)
- Uncontrolled pain or spasticity in the affected arm (Lang et al., 2016).
- History of shoulder instability or major orthopedic surgery in the affected arm (Gracies et al., 2019).
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
The University of Lahore Teaching Hospital
Lahore, Punjab Province, 54590
About this study
Official title: Comparative Effects of Constraint-Induced Movement Therapy (CIMT) with Motor Relearning Program (MRP) and Bobath Approach to Augment Functional Motor Recovery of Chronic Hemiparetic Arm
Hemiparesis is a condition characterized by weakness or the inability to move on one side of the body, making it difficult to perform everyday activities like eating or dressing (Iswatun et al., 2022). It is a common after-effect of stroke that causes weakness on one side of the body, limiting movement and affecting all basic activities such as dressing, eating, and walking. Hemiparesis can also be a sign of a stroke, and the side of the body weakened by hemiparesis could be ipsilateral (the same side as the brain injury) or contralateral (the opposite side of the brain injury) (Obman, 2020).
The symptoms of hemiparesis include: Weakness, Difficulty walking, Loss of balance, Muscle fatigue, Difficulty with coordination, Inability to grasp objects. Additionally, a person with hemiparesis may experience trouble maintaining balance, standing, or walking, as well as a tingling or numbing sensation on the weak side (Brandstaedter \& Lindenbaum, 2023). Difficulty grabbing things, moving with precision, and lack of coordination can also be present. Hemiparesis is a one-sided muscle weakness that can affect all or most of the anatomical segments on one side of the body (Dantes et al., 2020).
Constraint-Induced Movement Therapy (MCIMT) with combination of Motor Relearning Program (MRP) has significant effects on stroke rehabilitation. CIMT is considered to achieve its beneficial effects through mechanisms such as overcoming learned nonuse and use-dependent neural plasticity. However, in case of Bobath there in no such evidence. Therefore more studies are needed to evaluate the effects of CIMT with MRP and Bobath only in both acute and chronic post-stroke populations. Therefore, the aim of this research is to focus on rehabilitation of hemiparetic arm. This present study compared the effects of CIMT with MRP versus Bobath to Augment Functional Motor Recovery of Chronic Hemiparetic Arm.
Read the detailed description
To determine the comparative effects of constraint-induced movement therapy (CIMT) with motor relearning program (MRP) and Bobath therapy to augment functional motor recovery of chronic hemiparetic arm.
Study Design: Randomized Control Trial
Study Setting: The data was collected from the University of Lahore Teaching Hospital and Sehat Medical Complex , Lahore.
Study Duration: 9 months after the approval of synopsis.
Sampling technique: It was purposive sampling technique.
Sample size: The sample size was 56 (28 in each group ) in each group calculated through software
Group A (CIMT +MRP)
Group B (Bobath)
Screening: Patients were screened to meet inclusion criteria. The consent form was taken from patients then patients will be randomly allocated into two groups ( 28 in each group).
Randomization: Patients fulfilling the inclusion criteria were randomly divided into experimental and control groups using the computer software.
Blinding: The study was single-blinded. The assessor was unaware of the treatment given to both groups.
Assessment: Data was collected at baseline, third and then at the end of the six week. Baseline assessments was conducted before the intervention. Post-intervention assessments were conducted immediately after the intervention. Statistical analysis included descriptive statistics, normality test and analysis of variance to compare the outcomes between the two groups.
Treatment Plan:
Both CIMT with MRP and Bobath both groups received 6 weeks of therapy, 5 days per week, for 3 hours/day per session. Each session was divided into phases: warm-up, active intervention, cool-down.Therapists monitored participant progress and adjust difficulty levels as needed. Home exercise programs was provided for daily practice.
Ethical Considerations: This study has received ethical approval from the Institutional Review Board (IRB). Informed consent was obtained from all participants.
Data Analysis: Statistical software was used to analyze the data, with appropriate tests employed based on data normality to compare outcomes between groups.
- Being tested
- Constraint-Induced Movement Therapy (CIMT) With Motor Relearning Program (MRP), Bobath Therapy
- Keywords
- Constraint-Induced Movement Therapy (CIMT), Motor Relearning Program (MRP), Bobath Therapy, Stroke Rehabilitation, Upper Limb Hemiparesis, Motor Function Recovery
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constraint-Induced Movement Therapy (CIMT) With Motor Relearning Program (MRP)Behavioural
Intensive training sessions of 3 hours/day for 6 weeks, focusing on functional tasks with the paretic arm while constraining the unaffected arm using a mitt or sling. Implement a constraint on the non-paretic arm to encourage increased use of the affected arm in daily activities. Use shaping techniques to gradually increase the complexity and difficulty of tasks performed with the affected arm (Rahman, 2016).
MRP: Standard physiotherapy sessions of 1 hour/day for 6 weeks, including exercises for both affected and unaffected arm. Focus on improving strength, range of motion, and coordination through repetitive task practice, neuromuscular re-education and compensatory strategies (Brkić, 2016; Ghrouz et al., 2023).
Bobath TherapyBehavioural
The first step in the Bobath approach is a thorough assessment of the individual's movement patterns, muscle tone, strength, coordination, and functional abilities. This assessment helps in identifying specific impairments and setting goals for treatment. Bobath therapists use specific handling techniques to facilitate normal movement patterns and inhibit abnormal muscle tone. These hands-on techniques aim to promote efficient movement and improve motor control. The Bobath approach emphasizes task-oriented training, where functional activities relevant to the individual's daily life are incorporated into therapy sessions. This helps in improving motor skills in a context that is meaningful to the individual (Grozdek Čovčić et al., 2022; Kuciel et al., 2021).
| Study group | Role | What they receive |
|---|---|---|
| Constraint-Induced Movement Therapy (CIMT) with the Motor Relearning Program (MRP) | Experimental | Intensive training sessions focusing on the paretic arm. The unaffected arm is constrained using a mitt or sling to encourage using the affected limb. Emphasis on repetitive practice of functional tasks to enhance motor learning and skill acquisition. MRP Components: Standard physiotherapy sessions emphasizing strength, range of motion, and coordination. Task-specific training and neuromuscular re-education to improve motor function. Therapy sessions are conducted five days a week for six weeks, with additional home exercise programs to reinforce skills. Receives: Behavioral: Constraint-Induced Movement Therapy (CIMT) With Motor Relearning Program (MRP) |
| Bobath therapy | Experimental | Bobath therapy is a task-oriented approach focusing on balance, postural control, and the facilitation of normal movement patterns to improve motor skills and independence. It aims to inhibit abnormal muscle tone and promote efficient motor strategies. Receives: Behavioral: Bobath Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment (FMA)
The Fugl-Meyer Assessment (FMA) is a widely used clinical tool designed to evaluate motor impairment, balance, sensation, and joint functioning in individuals with post-stroke hemiplegia. It consists of various items that assess motor function in the upper and lower extremities, providing a comprehensive measure of motor recovery post-stroke.
Measured: Baseline, mid-intervention (3 weeks), and post-intervention (6 weeks).
Modified Ashworth Scale (MAS)
The Modified Ashworth Scale (MAS) is a 6-point scale used to assess spasticity in patients with lesions to the central nervous system. Scores on the MAS range from 0 to 4, where lower scores represent normal muscle tone and higher scores indicate increased spasticity. The MAS assigns a grade of spasticity based on resistance encountered during passive movement, with a grade of 0 indicating no increase in muscle tone and a grade of 4 representing limb rigidity in flexion or extension.
Measured: Baseline, mid-intervention (3 weeks), and post-intervention (6 weeks).
Secondary outcomes (1)
Pain
The Numeric Pain Rating Scale is a widely utilized tool for assessing pain intensity in adults. It operates on an 11-point scale ranging from 0 to 10, where 0 indicates no pain and 10 represents the worst pain imaginable. Higher scores on this scale signify greater pain intensity, making it a straightforward method for patients to communicate their pain levels to healthcare providers.
Measured: Baseline, mid-intervention (3 weeks), and post-intervention (6 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start26 Jan 2024
- Primary completion11 Nov 2024
- Study completion21 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Randomised
- Intervention model
- Parallel groups
- Model description
- For a study comparing the effects of Constraint-Induced Movement Therapy (CIMT) combined with Motor Relearning Program (MRP) and Bobath therapy on functional motor recovery in patients with chronic hemiparesis.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Ahad, University of Lahore Hospital (ULH)
- Investigators
- Faiza Sharif, PhD.PT, Principal investigator, University of LahoreArooj Fatima, Phd.PT, Study director, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06806553
- Sponsor's protocol ID
- Rec-UOL-/199/08/24
- Acronym
- CIMT-MRP
- Status last verified
- Jan 2025
- First submitted
- 28 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lang CE, Strube MJ, Bland MD, Waddell KJ, Cherry-Allen KM, Nudo RJ, Dromerick AW, Birkenmeier RL. Dose response of task-specific upper limb training in people at least 6 months poststroke: A phase II, single-blind, randomized, controlled trial. Ann Neurol. 2016 Sep;80(3):342-54. doi: 10.1002/ana.24734. Epub 2016 Aug 16.
PubMed 27447365Jan S, Arsh A, Darain H, Gul S. A randomized control trial comparing the effects of motor relearning programme and mirror therapy for improving upper limb motor functions in stroke patients. J Pak Med Assoc. 2019 Sep;69(9):1242-1245.
PubMed 31511706Grozdek Covcic G, Jurak I, Telebuh M, Macek Z, Bertic Z, Zura N, Grubisic M, Matic H, Tislar MH, Jakus L. Effects of Bobath treatment and specific mobilizations on gait in stroke patients: A randomized clinical trial. NeuroRehabilitation. 2022;50(4):493-500. doi: 10.3233/NRE-210326.
PubMed 35311720Gracies JM, Pradines M, Ghedira M, Loche CM, Mardale V, Hennegrave C, Gault-Colas C, Audureau E, Hutin E, Baude M, Bayle N; Neurorestore Study Group. Guided Self-rehabilitation Contract vs conventional therapy in chronic stroke-induced hemiparesis: NEURORESTORE, a multicenter randomized controlled trial. BMC Neurol. 2019 Mar 12;19(1):39. doi: 10.1186/s12883-019-1257-y.
PubMed 30871480Ghrouz A, Guillen-Sola A, Morgado-Perez A, Munoz-Redondo E, Ramirez-Fuentes C, Curbelo Pena Y, Duarte E. The effect of a motor relearning on balance and postural control in patients after stroke: An open-label randomized controlled trial. Eur Stroke J. 2024 Jun;9(2):303-311. doi: 10.1177/23969873231220218. Epub 2023 Dec 29.
PubMed 38158722
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Constraint-Induced Movement Therapy (CIMT) with Motor Relearning Program (MRP) and Bobath Approach to Augment Functional Motor Recovery of Chronic Hemiparetic Arm
- ClinicalTrials.gov ID
- NCT06806553
- Acronym / sponsor ID
- CIMT-MRP / Rec-UOL-/199/08/24
- Keywords
- Constraint-Induced Movement Therapy (CIMT), Motor Relearning Program (MRP), Bobath Therapy, Stroke Rehabilitation, Upper Limb Hemiparesis, Motor Function Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 26 Jan 2024 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 21 Dec 2024 (actual)
- First posted
- 4 Feb 2025 (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.
Hemiparesis is a condition characterized by weakness or the inability to move on one side of the body, making it difficult to perform everyday activities like eating or dressing (Iswatun et al., 2022). It is a common after-effect of stroke that causes weakness on one side of the body, limiting movement and affecting all basic activities such as dressing, eating, and walking. Hemiparesis can also be a sign of a stroke, and the side of the body weakened by hemiparesis could be ipsilateral (the same side as the brain injury) or contralateral (the opposite side of the brain injury) (Obman, 2020).
The symptoms of hemiparesis include: Weakness, Difficulty walking, Loss of balance, Muscle fatigue, Difficulty with coordination, Inability to grasp objects. Additionally, a person with hemiparesis may experience trouble maintaining balance, standing, or walking, as well as a tingling or numbing sensation on the weak side (Brandstaedter \& Lindenbaum, 2023). Difficulty grabbing things, moving with precision, and lack of coordination can also be present. Hemiparesis is a one-sided muscle weakness that can affect all or most of the anatomical segments on one side of the body (Dantes et al., 2020).
Constraint-Induced Movement Therapy (MCIMT) with combination of Motor Relearning Program (MRP) has significant effects on stroke rehabilitation. CIMT is considered to achieve its beneficial effects through mechanisms such as overcoming learned nonuse and use-dependent neural plasticity. However, in case of Bobath there in no such evidence. Therefore more studies are needed to evaluate the effects of CIMT with MRP and Bobath only in both acute and chronic post-stroke populations. Therefore, the aim of this research is to focus on rehabilitation of hemiparetic arm. This present study compared the effects of CIMT with MRP versus Bobath to Augment Functional Motor Recovery of Chronic Hemiparetic Arm.
Detailed description
To determine the comparative effects of constraint-induced movement therapy (CIMT) with motor relearning program (MRP) and Bobath therapy to augment functional motor recovery of chronic hemiparetic arm.
Study Design: Randomized Control Trial
Study Setting: The data was collected from the University of Lahore Teaching Hospital and Sehat Medical Complex , Lahore.
Study Duration: 9 months after the approval of synopsis.
Sampling technique: It was purposive sampling technique.
Sample size: The sample size was 56 (28 in each group ) in each group calculated through software
Group A (CIMT +MRP)
Group B (Bobath)
Screening: Patients were screened to meet inclusion criteria. The consent form was taken from patients then patients will be randomly allocated into two groups ( 28 in each group).
Randomization: Patients fulfilling the inclusion criteria were randomly divided into experimental and control groups using the computer software.
Blinding: The study was single-blinded. The assessor was unaware of the treatment given to both groups.
Assessment: Data was collected at baseline, third and then at the end of the six week. Baseline assessments was conducted before the intervention. Post-intervention assessments were conducted immediately after the intervention. Statistical analysis included descriptive statistics, normality test and analysis of variance to compare the outcomes between the two groups.
Treatment Plan:
Both CIMT with MRP and Bobath both groups received 6 weeks of therapy, 5 days per week, for 3 hours/day per session. Each session was divided into phases: warm-up, active intervention, cool-down.Therapists monitored participant progress and adjust difficulty levels as needed. Home exercise programs was provided for daily practice.
Ethical Considerations: This study has received ethical approval from the Institutional Review Board (IRB). Informed consent was obtained from all participants.
Data Analysis: Statistical software was used to analyze the data, with appropriate tests employed based on data normality to compare outcomes between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- For a study comparing the effects of Constraint-Induced Movement Therapy (CIMT) combined with Motor Relearning Program (MRP) and Bobath therapy on functional motor recovery in patients with chronic hemiparesis.
| Arm | Type | Receives |
|---|---|---|
| Constraint-Induced Movement Therapy (CIMT) with the Motor Relearning Program (MRP) | Experimental | Behavioral: Constraint-Induced Movement Therapy (CIMT) With Motor Relearning Program (MRP)Intensive training sessions focusing on the paretic arm. The unaffected arm is constrained using a mitt or sling to encourage using the affected limb. Emphasis on repetitive practice of functional tasks to enhance motor learning and skill acquisition. MRP Components: Standard physiotherapy sessions emphasizing strength, range of motion, and coordination. Task-specific training and neuromuscular re-education to improve motor function. Therapy sessions are conducted five days a week for six weeks, with additional home exercise programs to reinforce skills. |
| Bobath therapy | Experimental | Behavioral: Bobath TherapyBobath therapy is a task-oriented approach focusing on balance, postural control, and the facilitation of normal movement patterns to improve motor skills and independence. It aims to inhibit abnormal muscle tone and promote efficient motor strategies. |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosed with chronic hemiparesis at least 6 months prior to study enrollment (Lang et al., 2016).
- Chronic hemiparesis affecting one arm only (Lang et al., 2016).
- Age between 50 and 65 years old (Lang et al., 2016).
- Patients experiencing functional limitations in upper limb motor function (Gracies et al., 2019).
- Mini-Mental State Examination (MMSE) score ≥ 24 (Page et al., 2007).
Key exclusion criteria (4 listed)
- Recent acute medical/surgical condition unrelated to stroke (Lang et al., 2016).
- Severe cognitive impairment or communication difficulties (Lang et al., 2016)
- Uncontrolled pain or spasticity in the affected arm (Lang et al., 2016).
- History of shoulder instability or major orthopedic surgery in the affected arm (Gracies et al., 2019).
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 |
|---|---|---|
| Constraint-Induced Movement Therapy (CIMT) With Motor Relearning Program (MRP)Intensive training sessions of 3 hours/day for 6 weeks, focusing on functional tasks with the paretic arm while constraining the unaffected arm using a mitt or sling. Implement a constraint on the non-paretic arm to encourage increased use of the affected arm in daily activities. Use shaping techniques to gradually increase the complexity and difficulty of tasks performed with the affected arm (Rahman, 2016). MRP: Standard physiotherapy sessions of 1 hour/day for 6 weeks, including exercises for both affected and unaffected arm. Focus on improving strength, range of motion, and coordination through repetitive task practice, neuromuscular re-education and compensatory strategies (Brkić, 2016; Ghrouz et al., 2023). | Behavioural | Constraint-Induced Movement Therapy (CIMT) with the Motor Relearning Program (MRP) |
| Bobath TherapyThe first step in the Bobath approach is a thorough assessment of the individual's movement patterns, muscle tone, strength, coordination, and functional abilities. This assessment helps in identifying specific impairments and setting goals for treatment. Bobath therapists use specific handling techniques to facilitate normal movement patterns and inhibit abnormal muscle tone. These hands-on techniques aim to promote efficient movement and improve motor control. The Bobath approach emphasizes task-oriented training, where functional activities relevant to the individual's daily life are incorporated into therapy sessions. This helps in improving motor skills in a context that is meaningful to the individual (Grozdek Čovčić et al., 2022; Kuciel et al., 2021). | Behavioural | Bobath therapy |
Primary outcome
Fugl-Meyer Assessment (FMA)
Time frame: Baseline, mid-intervention (3 weeks), and post-intervention (6 weeks).
The Fugl-Meyer Assessment (FMA) is a widely used clinical tool designed to evaluate motor impairment, balance, sensation, and joint functioning in individuals with post-stroke hemiplegia. It consists of various items that assess motor function in the upper and lower extremities, providing a comprehensive measure of motor recovery post-stroke.
Modified Ashworth Scale (MAS)
Time frame: Baseline, mid-intervention (3 weeks), and post-intervention (6 weeks).
The Modified Ashworth Scale (MAS) is a 6-point scale used to assess spasticity in patients with lesions to the central nervous system. Scores on the MAS range from 0 to 4, where lower scores represent normal muscle tone and higher scores indicate increased spasticity. The MAS assigns a grade of spasticity based on resistance encountered during passive movement, with a grade of 0 indicating no increase in muscle tone and a grade of 4 representing limb rigidity in flexion or extension.
1 secondary outcome
Pain
Time frame: Baseline, mid-intervention (3 weeks), and post-intervention (6 weeks).
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 4 Feb 2025.
- Background: PubMed 27447365Lang CE, Strube MJ, Bland MD, Waddell KJ, Cherry-Allen KM, Nudo RJ, Dromerick AW, Birkenmeier RL. Dose response of task-specific upper limb training in people at least 6 months poststroke: A phase II, single-blind, randomized, controlled trial. Ann Neurol. 2016 Sep;80(3):342-54. doi: 10.1002/ana.24734. Epub 2016 Aug 16.
- Background: PubMed 31511706Jan S, Arsh A, Darain H, Gul S. A randomized control trial comparing the effects of motor relearning programme and mirror therapy for improving upper limb motor functions in stroke patients. J Pak Med Assoc. 2019 Sep;69(9):1242-1245.
- Background: PubMed 35311720Grozdek Covcic G, Jurak I, Telebuh M, Macek Z, Bertic Z, Zura N, Grubisic M, Matic H, Tislar MH, Jakus L. Effects of Bobath treatment and specific mobilizations on gait in stroke patients: A randomized clinical trial. NeuroRehabilitation. 2022;50(4):493-500. doi: 10.3233/NRE-210326.
- Background: PubMed 30871480Gracies JM, Pradines M, Ghedira M, Loche CM, Mardale V, Hennegrave C, Gault-Colas C, Audureau E, Hutin E, Baude M, Bayle N; Neurorestore Study Group. Guided Self-rehabilitation Contract vs conventional therapy in chronic stroke-induced hemiparesis: NEURORESTORE, a multicenter randomized controlled trial. BMC Neurol. 2019 Mar 12;19(1):39. doi: 10.1186/s12883-019-1257-y.
- Background: PubMed 38158722Ghrouz A, Guillen-Sola A, Morgado-Perez A, Munoz-Redondo E, Ramirez-Fuentes C, Curbelo Pena Y, Duarte E. The effect of a motor relearning on balance and postural control in patients after stroke: An open-label randomized controlled trial. Eur Stroke J. 2024 Jun;9(2):303-311. doi: 10.1177/23969873231220218. Epub 2023 Dec 29.
- Individual participant dataSharing planned: Undecided
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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.
Faiza Sharif, PhD.PT principal investigator
University of Lahore
Arooj Fatima, Phd.PT study director
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constraint-Induced Movement Therapy (CIMT) With Motor Relearning Program (MRP) and Bobath Therapy in people with Stroke and Hemiparesis, run by University of Lahore at 1 site in Pakistan.
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 4 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 4 Feb 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 Pakistan. 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?
Fugl-Meyer Assessment (FMA) (time frame: Baseline, mid-intervention (3 weeks), and post-intervention (6 weeks).). The study lists 2 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 NCT06806553, which also lists 5 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 4 Feb 2025.