StrokeNCT06407830
Effect of MRP With and Without EMS on Gait, Functional Independence and QOL in Stroke Patients
A study testing motor relearning programme and electrical muscle stimulations with motor relearning programme in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effects of motor relearning programme with and without electrical muscle stimulation on gait, functional independence and quality of life in hemiplegic stroke patients. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- motor relearning programme and electrical muscle stimulations with motor relearning programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2024to Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed as hemiplegic stroke
- Age between 45-65 years
- Both males and females
- Mini-Mental State Examination score ≥24
- Able to stand independently for at least 1 min and (5) can ambulate 25 feet/10 m (with or without the assistive device)
Who cannot join
- Experiencing balance problems as a result of neurological conditions other than stroke (for instance cerebellar impairment, inner ear dysfunction, or Parkinson's disease)
- Fixed ankle or foot contracture.
- A serious cardiac disease (aorta stenosis, angina, hypertrophic cardiomyopathy, arrhythmia and pacemakers).
- congenital limb deformities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Rehabilitation Center
Lahore, Punjab Province, 54600
wajiha shahid, PhD, 03214885079, wajishahid89@gmail.com
Rashida Arshad, MSNMPT*
About this study
Official title: Effects of Motor Relearning Program With and Without Electrical Muscle Stimulation on Gait, Functional Independence and Quality of Life in Hemiplegic Stroke Patients
To determine the effects of motor relearning programme with and without electrical muscle stimulation on gait, functional independence and quality of life in hemiplegic stroke patients.
Read the detailed description
A study was performed a motor relearning program in stroke survivors. A clinically significant improvement was found in the motor relearning groups, and only in one study is this improvement significant compared to another intervention.
Neuromuscular Electrical Stimulation Improves Activities of Daily Living Post-Stroke. While the potential for enhancing functional motor ability seems less clear, the current systematic review and meta analysis's results point to a significant positive impact of NMES on ADL function during the post stroke rehabilitation process.
People with hemiparesis who received both conventional treatment and interventions based on motor relearning showed a significant improvement in their level of disability. There were no appreciable gains in the HRQoL perception.
Many research investigations have been carried out to assess the effects of motor relearning programs with regard to specific functional aspects and physical deficiencies. Up to the researcher's knowledge, there is no data to assess the effects of electrical muscle stimulation along with motor relearning programs in stroke patients. Therefore, the purpose of this study is to compare how a motor relearning program with and without electrical muscle stimulation affects hemiplegic stroke patients' gait, level of functional independence, and quality of life.
- Conditions
- Stroke
- Being tested
- motor relearning programme, electrical muscle stimulations with motor relearning programme
- Keywords
- Gait, Functional independence, Quality of life
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motor relearning programmeOther
Treatment protocol includes Brief period of warm up and cool down (5 minutes). Individuals of this group will be provided 3 sessions per week; 1 hour per session; 24 sessions of task specific training based on the motor relearning programme. Each task specific training consists of 10 minutes.
electrical muscle stimulations with motor relearning programmeOther
Treatment protocol includes Brief period of warm up and cool down (5 minutes). Individuals of this group will be provided 3 sessions per week; 1 hour per session; 24 sessions of task specific training based on the motor relearning programme. Each task specific training consists of 10 minutes.
Individuals of this group will be provided 3 sessions per week; 1 hour per session; 24 sessions for 8 weeks task specific training based on the motor relearning programme and 10 minutes of the EMS of each muscle during the session.
| Study group | Role | What they receive |
|---|---|---|
| Intervention physical therapy | Active comparator | Motor Relearning programme training Receives: Other: motor relearning programme |
| Electrical Muscle Stimulation | Experimental | Electrical Muscle Stimulation with Motor Relearning programme Receives: Other: motor relearning programme; Other: electrical muscle stimulations with motor relearning programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence Measurement (FIM).
The Functional Independence Measure (FIM) instrument was applied to assess the changes in functional ability. Out of the eighteen items in the FIM, thirteen evaluate physical domains and five evaluate cognitive functions. Each item is scored from 1 to 7 ("1" total dependence; "7" complete independence). The final score ranges from 18 to 126.
Measured: baseline week 1 and post interventional week 8
Secondary outcomes (2)
Dynamic Gait Index
The DGI has 8 items: walking, walking while changing speed, walking while turning the head horizontally and vertically, walking with pivot turn, walking over and around obstacles, and stair climbing. The scoring of the DGI is based on a 4-point scale ranging from 0 to 3, with 0 indicating severe impairment and 3 indicating normal ability. The best performance total score is 24. A low composite DGI score thus indicates greater impairment in functional mobility.
Measured: baseline week 1 and post interventional week 8
Stroke specific quality of life
The SSQOL is a valid, reliable measurement that assesses health-related quality of life in stroke subjects and consists of a 49-item scale (each scored 1-5) representing 12 domains, for a maximum score of 245. All subjects were assessed while not wearing the treatment device.
Measured: baseline week 1 and post interventional week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start1 May 2024
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aruba Saeed, PhD, Principal investigator, Riphah International University (Lahore)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407830
- Sponsor's protocol ID
- REC/RCR&AHS/23/0278
- Status last verified
- Dec 2024
- First submitted
- 6 May 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ghrouz A, Marco E, Munoz-Redondo E, Boza R, Ramirez-Fuentes C, Duarte E. The effect of motor relearning on balance, mobility and performance of activities of daily living among post-stroke patients: Study protocol for a randomised controlled trial. Eur Stroke J. 2022 Mar;7(1):76-84. doi: 10.1177/23969873211061027. Epub 2022 Feb 11.
PubMed 35300258Paolucci T, Agostini F, Mussomeli E, Cazzolla S, Conti M, Sarno F, Bernetti A, Paoloni M, Mangone M. A rehabilitative approach beyond the acute stroke event: a scoping review about functional recovery perspectives in the chronic hemiplegic patient. Front Neurol. 2023 Sep 15;14:1234205. doi: 10.3389/fneur.2023.1234205. eCollection 2023.
PubMed 37789885Mesci N, Ozdemir F, Kabayel DD, Tokuc B. The effects of neuromuscular electrical stimulation on clinical improvement in hemiplegic lower extremity rehabilitation in chronic stroke: a single-blind, randomised, controlled trial. Disabil Rehabil. 2009;31(24):2047-54. doi: 10.3109/09638280902893626.
PubMed 19874084
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Motor Relearning Program With and Without Electrical Muscle Stimulation on Gait, Functional Independence and Quality of Life in Hemiplegic Stroke Patients
- ClinicalTrials.gov ID
- NCT06407830
- Acronym / sponsor ID
- REC/RCR&AHS/23/0278
- Conditions
- Stroke
- Keywords
- Gait, Functional independence, Quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 9 May 2024 (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.
To determine the effects of motor relearning programme with and without electrical muscle stimulation on gait, functional independence and quality of life in hemiplegic stroke patients.
Detailed description
A study was performed a motor relearning program in stroke survivors. A clinically significant improvement was found in the motor relearning groups, and only in one study is this improvement significant compared to another intervention.
Neuromuscular Electrical Stimulation Improves Activities of Daily Living Post-Stroke. While the potential for enhancing functional motor ability seems less clear, the current systematic review and meta analysis's results point to a significant positive impact of NMES on ADL function during the post stroke rehabilitation process.
People with hemiparesis who received both conventional treatment and interventions based on motor relearning showed a significant improvement in their level of disability. There were no appreciable gains in the HRQoL perception.
Many research investigations have been carried out to assess the effects of motor relearning programs with regard to specific functional aspects and physical deficiencies. Up to the researcher's knowledge, there is no data to assess the effects of electrical muscle stimulation along with motor relearning programs in stroke patients. Therefore, the purpose of this study is to compare how a motor relearning program with and without electrical muscle stimulation affects hemiplegic stroke patients' gait, level of functional independence, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention physical therapy | Active comparator | Other: motor relearning programmeMotor Relearning programme training |
| Electrical Muscle Stimulation | Experimental | Other: motor relearning programme, Other: electrical muscle stimulations with motor relearning programmeElectrical Muscle Stimulation with Motor Relearning programme |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed as hemiplegic stroke
Key exclusion criteria (4 listed)
- Experiencing balance problems as a result of neurological conditions other than stroke (for instance cerebellar impairment, inner ear dysfunction, or Parkinson's disease)
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 |
|---|---|---|
| motor relearning programmeTreatment protocol includes Brief period of warm up and cool down (5 minutes). Individuals of this group will be provided 3 sessions per week; 1 hour per session; 24 sessions of task specific training based on the motor relearning programme. Each task specific training consists of 10 minutes. | Other | Electrical Muscle Stimulation, Intervention physical therapy |
| electrical muscle stimulations with motor relearning programmeTreatment protocol includes Brief period of warm up and cool down (5 minutes). Individuals of this group will be provided 3 sessions per week; 1 hour per session; 24 sessions of task specific training based on the motor relearning programme. Each task specific training consists of 10 minutes. Individuals of this group will be provided 3 sessions per week; 1 hour per session; 24 sessions for 8 weeks task specific training based on the motor relearning programme and 10 minutes of the EMS of each muscle during the session. | Other | Electrical Muscle Stimulation |
Primary outcome
Functional Independence Measurement (FIM).
Time frame: baseline week 1 and post interventional week 8
The Functional Independence Measure (FIM) instrument was applied to assess the changes in functional ability. Out of the eighteen items in the FIM, thirteen evaluate physical domains and five evaluate cognitive functions. Each item is scored from 1 to 7 ("1" total dependence; "7" complete independence). The final score ranges from 18 to 126.
2 secondary outcomes
Dynamic Gait Index
Time frame: baseline week 1 and post interventional week 8
Stroke specific quality of life
Time frame: baseline week 1 and post interventional week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Background: PubMed 35300258Ghrouz A, Marco E, Munoz-Redondo E, Boza R, Ramirez-Fuentes C, Duarte E. The effect of motor relearning on balance, mobility and performance of activities of daily living among post-stroke patients: Study protocol for a randomised controlled trial. Eur Stroke J. 2022 Mar;7(1):76-84. doi: 10.1177/23969873211061027. Epub 2022 Feb 11.
- Background: PubMed 37789885Paolucci T, Agostini F, Mussomeli E, Cazzolla S, Conti M, Sarno F, Bernetti A, Paoloni M, Mangone M. A rehabilitative approach beyond the acute stroke event: a scoping review about functional recovery perspectives in the chronic hemiplegic patient. Front Neurol. 2023 Sep 15;14:1234205. doi: 10.3389/fneur.2023.1234205. eCollection 2023.
- Background: PubMed 19874084Mesci N, Ozdemir F, Kabayel DD, Tokuc B. The effects of neuromuscular electrical stimulation on clinical improvement in hemiplegic lower extremity rehabilitation in chronic stroke: a single-blind, randomised, controlled trial. Disabil Rehabil. 2009;31(24):2047-54. doi: 10.3109/09638280902893626.
- 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.
Aruba Saeed, PhD principal investigator
Riphah International University (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 motor relearning programme and electrical muscle stimulations with motor relearning programme in people with Stroke, run by Riphah International University 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 5 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: looking for participants now, as of the sponsor's last update on 27 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PhD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Independence Measurement (FIM). (time frame: baseline week 1 and post interventional week 8). 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 NCT06407830, which also lists 3 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 27 Dec 2024.