Chronic StrokeNCT06674590
Effects of Motor Relearning Program Versus Proprioceptive Neuromuscular Facilitation on Balance and Gait in Stroke
A study testing Proprioceptive Neuromuscular Facilitation and Motor Relearning Program in people with Chronic Stroke and Proprioceptive Neuromuscular Facilitation, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
A randomized control trial will be done on diagnosed stroke patients of chronic stage in DHQ Hospital Mirpur and FF Hospital Rawalpindi physical therapy Department.The purpose of the study is to determine Effects of Motor Relearning Program Versus Proprioceptive Neuromuscular Facilitation on Balance and Gait in Stroke… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Chronic Stroke, Proprioceptive Neuromuscular Facilitation, Balance
- What is being tested?
- Proprioceptive Neuromuscular Facilitation and Motor Relearning Program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Jun 2024to 20 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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- more than 6 month post stroke
- both male and female
- Can ambulate 25 feet/10 meter (with or without assistive device).
- Age between 25 to 65 years.
- Grades for MAS (Grade 2 0r less )/stage of brunstrom approach (stage 4 or up )
Who cannot join
- History of neurologic disease other than the chronic stroke.
- Orthopedic disorder involving any joint of lower limbs that interfere with study.
- Gross visuospatial deficits .
- Unhealed fracture of lowerlimb .
- Peripheral arterial occlusive disease.
- Uncontrolled hypertension and diabetes
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
Foundation University College of Physical Therapy
Islamabad, 44000
Nida Mushtaq Kayani, MS-NMPT, +923330418548, nida.mushtaq@fui.edu.pk
About this study
A randomized control trial will be done on diagnosed stroke patients of chronic stage in DHQ Hospital Mirpur and FF Hospital Rawalpindi physical therapy Department.The purpose of the study is to determine Effects of Motor Relearning Program Versus Proprioceptive Neuromuscular Facilitation on Balance and Gait in Stroke .
Subjects will complete Berg Balance Scale (BBS). 10-meter walk test for gait speed will be used for measuring walking speed in meters per second over a short distance, Timed-Up-And-Go (TUG) Test will be used for test of functional mobility and gait parameter. All these measures will be taken at baseline, then after 6 weeks of intervention. There will be 4 sessions per week. The control group will receive Group Motor relearning programe while the Study Group (B) will receive Proprioceptive Neuromuscular Facilitation(PNF)
Read the detailed description
OBJECTIVES:
The objectives of this study are:
- To determine the effects of Motor Relearning program Versus Proprioceptive Neuromuscular Facilitation for Improving Balance in stroke patient.
- To determine the effects of Motor Relearning program Versus ProprioceptiveNeuromuscular Facilitation on Gait Parameters in stroke patient.
HYPOTHESIS:
Alternate hypothesis:
Motor Relearning program as compared to Proprioceptive Neuromuscular Facilitation effective for balance and gait parameter in chronic stroke patient.
Null hypothesis:
Motor Relearning program as compared to Proprioceptive Neuromuscular Facilitation not effective for balance and gait parameter in chronic stroke patient.
Research Design: Experimental study. Randomized Control Trial
Clinical setting: DHQ Hospital Mirpur , Fauji Foundation Hospital . Study duration: 1 year
Selection Criteria:
Inclusion Criteria
- more than 6 month post stroke
- Can ambulate 25 feet/10 meter (with or without assistive device).
- Age between 25 to 65 years.
- Grades for MAS (Grade 2 0r less )/stage of brunstrom approach (stage 4 or up )
Exclusion Criteria
- History of neurologic disease other than the chronic stroke.
- Orthopedic disorder involving any joint of lower limbs that interfere with study.
- Gross visuospatial deficits .
- Unhealed fracture of lowerlimb .
- Peripheral arterial occlusive disease.
- Uncontrolled hypertension and diabetes .
Sampling technique: Non Proability Purposive sampling
Outcome Measures:
Data will be collected on Demographics and general information Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function .
10-meter walk test for gait speed The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance.
Timed-Up-And-Go (TUG) Test:
test of functional mobility in which the participant stands up from a standard armchair, walks to a line on the floor 3 m away, turns around, walks back to the chair, and sits dow
Control group (A) = MRP divided into different task , duration will be 30 minutes. MRP for sitting to standing MRP for stand to sit MRP for walking Training of hip extension throughout stance phase Training of knee control for stance phase Training of lateral horizontal pelvic shift Training of flexion of knee at start of swing phase Training of knee extension and foot dorsiflexion at heel strike Practice of walking Transference of training into daily Experimental Group (B) =PNF of 30 minutes duration will given in a single session.
Pelvic anterior elevation and posterior depression of the hemiplegic side. rhythmic initiation slow reversal agonistic reversals Pelvic anterior depression and posterior elevation of the hemiplegic side. The first diagonal (D1): Flexion and extension The second diagonal (D2): Flexion and extension
Data analysis techniques:
The data will be analyzed through SPSS 21 and Data would be analyzed based on the study design chosen that is random control experimental study.
A printed questionnaire will be provided to the participents after obtaining written consent and providing adequate explanation regarding the study, after which the data will be presented in the form of graphs or tables.
Significance of the study:
Proprioceptive Neuromuscular Facilitation compared to motor relearning program for chronic stroke patient may prove effectiveness in term of balance and gait parameters.
This study will help the practitioner to use the best treatment options for treating patients with stroke problem.
The results of the study will add to the literature about the effect of Proprioceptive Neuromuscular Facilitation as compared to motor relearning program for of balance and gait parameter in stroke patient.
- Being tested
- Proprioceptive Neuromuscular Facilitation, Motor Relearning Program
- Keywords
- Stroke, Motor relearning program, Proprioceptive neuromuscular facilitation, balance, gait, gait speed, stride length, cadence, cycle time
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive Neuromuscular FacilitationProcedure or surgery
PNF of 30 minutes duration will given in a single session. Pelvic anterior elevation and posterior depression of the hemiplegic side. rhythmic initiation slow reversal agonistic reversals Pelvic anterior depression and posterior elevation of the hemiplegic side. The first diagonal (D1): Flexion and extension The second diagonal (D2): Flexion and extension 4 session per week
Motor Relearning ProgramProcedure or surgery
Motor Relearning Programme (MRP) This is a task-oriented approach to help the control of movement, focusing on the relearning of daily activities.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group A | Experimental | It includes participants receiving proprioceptive neuromuscular facilitation physical therapy for chronic stroke patient's for balance and gait parameter for a period of 6 weeks. Receives: Procedure: Proprioceptive Neuromuscular Facilitation |
| Experimental group B | Experimental | It includes participants receiving motor relearning program physical therapy for chronic stroke patient's for balance and gait parameter for a period of 6 weeks. Receives: Procedure: Motor Relearning Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
gait parameter
measurements of how a person walks, by using 10 meter walk test and TUG
Measured: 6 weeks
Secondary outcomes (1)
Balance
an even distribution of weight enabling someone or something to remain upright and steady by using BBS
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start20 Jun 2024
- Primary completion20 Dec 2024 (estimated)
- Study completion20 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe 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
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674590
- Sponsor's protocol ID
- FUI/CTR/2024/49
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Motor Relearning Program Versus Proprioceptive Neuromuscular Facilitation on Balance and Gait in Stroke
- ClinicalTrials.gov ID
- NCT06674590
- Acronym / sponsor ID
- FUI/CTR/2024/49
- Keywords
- Stroke, Motor relearning program, Proprioceptive neuromuscular facilitation, balance, gait, gait speed, stride length, cadence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 20 Jan 2025 (estimated)
- First posted
- 5 Nov 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.
A randomized control trial will be done on diagnosed stroke patients of chronic stage in DHQ Hospital Mirpur and FF Hospital Rawalpindi physical therapy Department.The purpose of the study is to determine Effects of Motor Relearning Program Versus Proprioceptive Neuromuscular Facilitation on Balance and Gait in Stroke .
Subjects will complete Berg Balance Scale (BBS). 10-meter walk test for gait speed will be used for measuring walking speed in meters per second over a short distance, Timed-Up-And-Go (TUG) Test will be used for test of functional mobility and gait parameter. All these measures will be taken at baseline, then after 6 weeks of intervention. There will be 4 sessions per week. The control group will receive Group Motor relearning programe while the Study Group (B) will receive Proprioceptive Neuromuscular Facilitation(PNF)
Detailed description
OBJECTIVES:
The objectives of this study are:
- To determine the effects of Motor Relearning program Versus Proprioceptive Neuromuscular Facilitation for Improving Balance in stroke patient.
- To determine the effects of Motor Relearning program Versus ProprioceptiveNeuromuscular Facilitation on Gait Parameters in stroke patient.
HYPOTHESIS:
Alternate hypothesis:
Motor Relearning program as compared to Proprioceptive Neuromuscular Facilitation effective for balance and gait parameter in chronic stroke patient.
Null hypothesis:
Motor Relearning program as compared to Proprioceptive Neuromuscular Facilitation not effective for balance and gait parameter in chronic stroke patient.
Research Design: Experimental study. Randomized Control Trial
Clinical setting: DHQ Hospital Mirpur , Fauji Foundation Hospital . Study duration: 1 year
Selection Criteria:
Inclusion Criteria
- more than 6 month post stroke
- Can ambulate 25 feet/10 meter (with or without assistive device).
- Age between 25 to 65 years.
- Grades for MAS (Grade 2 0r less )/stage of brunstrom approach (stage 4 or up )
Exclusion Criteria
- History of neurologic disease other than the chronic stroke.
- Orthopedic disorder involving any joint of lower limbs that interfere with study.
- Gross visuospatial deficits .
- Unhealed fracture of lowerlimb .
- Peripheral arterial occlusive disease.
- Uncontrolled hypertension and diabetes .
Sampling technique: Non Proability Purposive sampling
Outcome Measures:
Data will be collected on Demographics and general information Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function .
10-meter walk test for gait speed The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance.
Timed-Up-And-Go (TUG) Test:
test of functional mobility in which the participant stands up from a standard armchair, walks to a line on the floor 3 m away, turns around, walks back to the chair, and sits dow
Control group (A) = MRP divided into different task , duration will be 30 minutes. MRP for sitting to standing MRP for stand to sit MRP for walking Training of hip extension throughout stance phase Training of knee control for stance phase Training of lateral horizontal pelvic shift Training of flexion of knee at start of swing phase Training of knee extension and foot dorsiflexion at heel strike Practice of walking Transference of training into daily Experimental Group (B) =PNF of 30 minutes duration will given in a single session.
Pelvic anterior elevation and posterior depression of the hemiplegic side. rhythmic initiation slow reversal agonistic reversals Pelvic anterior depression and posterior elevation of the hemiplegic side. The first diagonal (D1): Flexion and extension The second diagonal (D2): Flexion and extension
Data analysis techniques:
The data will be analyzed through SPSS 21 and Data would be analyzed based on the study design chosen that is random control experimental study.
A printed questionnaire will be provided to the participents after obtaining written consent and providing adequate explanation regarding the study, after which the data will be presented in the form of graphs or tables.
Significance of the study:
Proprioceptive Neuromuscular Facilitation compared to motor relearning program for chronic stroke patient may prove effectiveness in term of balance and gait parameters.
This study will help the practitioner to use the best treatment options for treating patients with stroke problem.
The results of the study will add to the literature about the effect of Proprioceptive Neuromuscular Facilitation as compared to motor relearning program for of balance and gait parameter in stroke patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group A | Experimental | Procedure: Proprioceptive Neuromuscular FacilitationIt includes participants receiving proprioceptive neuromuscular facilitation physical therapy for chronic stroke patient's for balance and gait parameter for a period of 6 weeks. |
| Experimental group B | Experimental | Procedure: Motor Relearning ProgramIt includes participants receiving motor relearning program physical therapy for chronic stroke patient's for balance and gait parameter for a period of 6 weeks. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- more than 6 month post stroke
- both male and female
- Can ambulate 25 feet/10 meter (with or without assistive device).
- Age between 25 to 65 years.
- Grades for MAS (Grade 2 0r less )/stage of brunstrom approach (stage 4 or up )
Key exclusion criteria (6 listed)
- History of neurologic disease other than the chronic stroke.
- Orthopedic disorder involving any joint of lower limbs that interfere with study.
- Gross visuospatial deficits .
- Unhealed fracture of lowerlimb .
- Peripheral arterial occlusive 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 |
|---|---|---|
| Proprioceptive Neuromuscular FacilitationPNF of 30 minutes duration will given in a single session. Pelvic anterior elevation and posterior depression of the hemiplegic side. rhythmic initiation slow reversal agonistic reversals Pelvic anterior depression and posterior elevation of the hemiplegic side. The first diagonal (D1): Flexion and extension The second diagonal (D2): Flexion and extension 4 session per week | Procedure or surgery | Experimental group A |
| Motor Relearning ProgramMotor Relearning Programme (MRP) This is a task-oriented approach to help the control of movement, focusing on the relearning of daily activities. | Procedure or surgery | Experimental group B |
Primary outcome
gait parameter
Time frame: 6 weeks
measurements of how a person walks, by using 10 meter walk test and TUG
1 secondary outcome
Balance
Time frame: 6 weeks
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 5 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proprioceptive Neuromuscular Facilitation and Motor Relearning Program in people with Chronic Stroke and Proprioceptive Neuromuscular Facilitation, run by Foundation University Islamabad 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 6 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 5 Nov 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 Muhammad Asif Tuseef, DPT (+923465129721, asiftuseef73@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gait parameter (time frame: 6 weeks). 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 5 Nov 2024.