- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05379998
Neural Mobilization Versus PNF Hold Relax Technique on Lower Extremity in Hemiplegic Stroke
November 24, 2022 updated by: Riphah International University
Comparison of Neural Mobilization and Proprioceptive Neuromuscular Facilitation Hold Relax Technique on Lower Limb Motor Function in Hemiplegic Stroke
Several studies about the effects of nerve mobilizations and stretching exercises have been conducted.
This study will contribute to describing the long term effects of these techniques on gait, motor function and quality of life in hemiplegic stroke patients and compare the effectiveness of both techniques.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Several studies about the effects of nerve mobilizations and stretching exercises have been conducted.
Evidence regarding the comparison of these two techniques is sparse and is based on different clinical experiences and a less number of studies with limited methodological design.
There has been no work regarding the long term effects of these two techniques in improving lower limb motor function in Hemiplegic stroke patients.
This study will contribute to describing the long term effects of these techniques on gait, motor function and quality of life in hemiplegic stroke patients and compare the effectiveness of both techniques.
A total of 54 patients diagnosed with Hemiplegic stroke will be selected for the collection of data according to the inclusion criteria.
Patients will be divided into two groups, Group A and Group B. Group A will receive sciatic nerve mobilization (sliding technique) and Group B will receive Proprioceptive neuromuscular mobilization Hold relax technique 3 days a week for 30 mins per day for 6 weeks.
Sciatic nerve mobilizations (sliding technique) will be performed for a duration of 1 minute each for 6 such sets with 60 seconds rest period followed by every set.
The Hold Relax Technique of Hamstring will be performed with each hold period lasting for 10 seconds followed by a relaxation phase of 10-15 seconds for 10 repetitions.
Data will be collected at baseline, after 3weeks and at 6 weeks after intervention from both groups.
Gait will be measured using TUG (Timed up and go), Quality of life will be measured using the Urdu version of SS-QOL(stroke-specific quality of life)and lower limb motor function will be measured using fugl Meyer scale(lower extremity)
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Rawalpindi, Pakistan
- Holly Family Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with subacute to chronic (3-12months) Hemiplegic Stroke.
- Both Genders.
- Age between 20 and 70 years.
- Patients classified as grade 2 and 3 as per the Modified Rankin scale.
- Patients with or without assistive devices.
Exclusion Criteria:
- Patients having cardiac disorders, rheumatic and orthopedic diseases that would impede the performance of the technique.
- Patients who have undergone some surgery recently.
- Patients having cognitive impairments.
- Contractures of the lower limb joints.
- Patients having associated Neurological Pathologies.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Group A(neural mobilization)
sciatic nerve mobilization(sliding technique)
|
Sciatic nerve mobilization (sliding technique) will be performed by a physical therapist.
The sciatic nerve mobilization technique improves the nerve mobility of the hemiparetic lower limb in a nervous system patient and is helpful in increasing the ROM of the lower limbs without resistance.
|
|
EXPERIMENTAL: Group B(PNF hold relax)
PNF hold relax technique of Hamstring muscle
|
Proprioceptive neuromuscular facilitation hold relaxation technique of hamstring muscle will be performed by the physical therapist three days a week for 6 weeks.
In the hold relax technique after reaching the point of resistance, an isometric contraction is performed against the resistance to get a pain free response.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fugl meyer(lower extremity)
Time Frame: baseline
|
The Fugl-Meyer Assessment is the most widely used standardized clinical scale designed to assess motor function, balance, sensation qualities and joint function in hemiplegic post-stroke patients.
The total motor score ranges from 0 to 100 including 28 points for the lower extremity and 6 scores for coordination/speed.
Sensation score ranges from 0 to 12, joint range of motion from 0 to 20 and joint pain from 0 to 20.
|
baseline
|
|
Fugl meyer(lower extremity)
Time Frame: 3 weeks
|
The Fugl-Meyer Assessment is the most widely used standardized clinical scale designed to assess motor function, balance, sensation qualities and joint function in hemiplegic post-stroke patients.
The total motor score ranges from 0 to 100 including 28 points for the lower extremity and 6 scores for coordination/speed.
Sensation score ranges from 0 to 12, joint range of motion from 0 to 20 and joint pain from 0 to 20.
|
3 weeks
|
|
Fugl meyer(lower extremity)
Time Frame: 6 weeks
|
The Fugl-Meyer Assessment is the most widely used standardized clinical scale designed to assess motor function, balance, sensation qualities and joint function in hemiplegic post-stroke patients.
The total motor score ranges from 0 to 100 including 28 points for the lower extremity and 6 scores for coordination/speed.
Sensation score ranges from 0 to 12, joint range of motion from 0 to 20 and joint pain from 0 to 20.
|
6 weeks
|
|
Timed up and go (TUG)
Time Frame: baseline
|
The timed up and Go test (TUG) is a sensitive and specific measure of the probability of falls among older adults.
This test is simple and used to measure the risk of falls, and the progress of walking, balance and sit to stand.
The TUG is a reliable, valid, and easy-to-administer clinical tool for assessing advanced functional mobility after a stroke.<10sec
shows complete independence for ambulation and transfers (with and without walking aid).
An older adult who takes ≥12 seconds to complete the TUG is at risk of falling.
|
baseline
|
|
Timed up and go (TUG)
Time Frame: 3 weeks
|
The timed up and Go test (TUG) is a sensitive and specific measure of the probability of falls among older adults.
This test is simple and used to measure the risk of falls, and the progress of walking, balance and sitting to stand.
The TUG is a reliable, valid, and easy-to-administer clinical tool for assessing advanced functional mobility after a stroke.<10sec
shows complete independence for ambulation and transfers (with and without walking aid).
An older adult who takes ≥12 seconds to complete the TUG is at risk of falling.
|
3 weeks
|
|
Timed up and go (TUG)
Time Frame: 6 weeks
|
The timed up and Go test (TUG) is a sensitive and specific measure of the probability of falls among older adults.
This test is simple and used to measure the risk of falls, and the progress of walking, balance and sitting to stand.
The TUG is a reliable, valid, and easy-to-administer clinical tool for assessing advanced functional mobility after a stroke.<10sec
shows complete independence for ambulation and transfers (with and without walking aid).
An older adult who takes ≥12 seconds to complete the TUG is at risk of falling.
|
6 weeks
|
|
Stroke specific quality of life (SS-QOL)
Time Frame: baseline
|
Stroke specific quality of life (SS-QOL) is a standard scale used to evaluate health as related to the quality of life, particularly in stroke patients.
Urdu version of the stroke-specific quality of life scale will be used.
The total score ranges from 49 to 245 with higher scores indicating higher quality of life.
The minimum score is 49.
|
baseline
|
|
Stroke specific quality of life (SS-QOL)
Time Frame: 3 weeks
|
Stroke specific quality of life (SS-QOL) is a standard scale used to evaluate health as related to the quality of life, particularly in stroke patients.
Urdu version of the stroke-specific quality of life scale will be used.
The total score ranges from 49 to 245 with higher scores indicating higher quality of life.
The minimum score is 49.
|
3 weeks
|
|
Stroke specific quality of life (SS-QOL)
Time Frame: 6 weeks
|
Stroke specific quality of life (SS-QOL) is a standard scale used to evaluate health as related to the quality of life, particularly in stroke patients.
Urdu version of the stroke-specific quality of life scale will be used.
The total score ranges from 49 to 245 with higher scores indicating higher quality of life.
The minimum score is 49.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 20, 2022
Primary Completion (ACTUAL)
November 20, 2022
Study Completion (ACTUAL)
November 20, 2022
Study Registration Dates
First Submitted
May 13, 2022
First Submitted That Met QC Criteria
May 13, 2022
First Posted (ACTUAL)
May 18, 2022
Study Record Updates
Last Update Posted (ACTUAL)
November 28, 2022
Last Update Submitted That Met QC Criteria
November 24, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/01244 Nida khan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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