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AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

Muhammad Asif Tuseef, DPT contact

+923465129721

asiftuseef73@gmail.com

Pakistan1 site, 1 recruiting
  • Foundation University College of Physical Therapy

    Islamabad, 44000

    Nida Mushtaq Kayani, MS-NMPT, +923330418548, nida.mushtaq@fui.edu.pk

    Recruiting

Other trials in Pakistan

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:

  1. To determine the effects of Motor Relearning program Versus Proprioceptive Neuromuscular Facilitation for Improving Balance in stroke patient.
  2. 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

  1. more than 6 month post stroke
  2. Can ambulate 25 feet/10 meter (with or without assistive device).
  3. Age between 25 to 65 years.
  4. Grades for MAS (Grade 2 0r less )/stage of brunstrom approach (stage 4 or up )

Exclusion Criteria

  1. History of neurologic disease other than the chronic stroke.
  2. Orthopedic disorder involving any joint of lower limbs that interfere with study.
  3. Gross visuospatial deficits .
  4. Unhealed fracture of lowerlimb .
  5. Peripheral arterial occlusive disease.
  6. 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 groups in NCT06674590
Study groupRoleWhat they receive
Experimental group AExperimentalIt 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 BExperimentalIt 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.

  1. gait parameter

    measurements of how a person walks, by using 10 meter walk test and TUG

    Measured: 6 weeks

Secondary outcomes (1)
  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.

  1. First posted5 Nov 2024
  2. Study start20 Jun 2024
  3. Primary completion20 Dec 2024 (estimated)
  4. Study completion20 Jan 2025 (estimated)

Resources

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)
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

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.

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