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Neural Mobilization Versus PNF Hold Relax Technique on Lower Extremity in Hemiplegic Stroke

Primary Purpose

Hemiplegic Stroke

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Neural mobilization
PNF hold relax technique
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegic Stroke focused on measuring Neural mobilization, PNF hold relax, stroke

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Holly Family Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A(neural mobilization)

Group B(PNF hold relax)

Arm Description

sciatic nerve mobilization(sliding technique)

PNF hold relax technique of Hamstring muscle

Outcomes

Primary Outcome Measures

Fugl meyer(lower extremity)
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.
Fugl meyer(lower extremity)
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.
Fugl meyer(lower extremity)
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.
Timed up and go (TUG)
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.
Timed up and go (TUG)
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.
Timed up and go (TUG)
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.
Stroke specific quality of life (SS-QOL)
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.
Stroke specific quality of life (SS-QOL)
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.
Stroke specific quality of life (SS-QOL)
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.

Secondary Outcome Measures

Full Information

First Posted
May 13, 2022
Last Updated
November 24, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05379998
Brief Title
Neural Mobilization Versus PNF Hold Relax Technique on Lower Extremity in Hemiplegic Stroke
Official Title
Comparison of Neural Mobilization and Proprioceptive Neuromuscular Facilitation Hold Relax Technique on Lower Limb Motor Function in Hemiplegic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 20, 2022 (Actual)
Primary Completion Date
November 20, 2022 (Actual)
Study Completion Date
November 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegic Stroke
Keywords
Neural mobilization, PNF hold relax, stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
This will be a single blinded study. The data will be coded and the analyst will also be blinded.
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A(neural mobilization)
Arm Type
Experimental
Arm Description
sciatic nerve mobilization(sliding technique)
Arm Title
Group B(PNF hold relax)
Arm Type
Experimental
Arm Description
PNF hold relax technique of Hamstring muscle
Intervention Type
Other
Intervention Name(s)
Neural mobilization
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
PNF hold relax technique
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fugl meyer(lower extremity)
Description
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.
Time Frame
baseline
Title
Fugl meyer(lower extremity)
Description
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.
Time Frame
3 weeks
Title
Fugl meyer(lower extremity)
Description
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.
Time Frame
6 weeks
Title
Timed up and go (TUG)
Description
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.
Time Frame
baseline
Title
Timed up and go (TUG)
Description
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.
Time Frame
3 weeks
Title
Timed up and go (TUG)
Description
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.
Time Frame
6 weeks
Title
Stroke specific quality of life (SS-QOL)
Description
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.
Time Frame
baseline
Title
Stroke specific quality of life (SS-QOL)
Description
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.
Time Frame
3 weeks
Title
Stroke specific quality of life (SS-QOL)
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imran Amjad, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holly Family Hospital
City
Rawalpindi
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Neural Mobilization Versus PNF Hold Relax Technique on Lower Extremity in Hemiplegic Stroke

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