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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05379998
Other study ID # REC/01244 Nida khan
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 20, 2022
Est. completion date November 20, 2022

Study information

Verified date November 2022
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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)


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date November 20, 2022
Est. primary completion date November 20, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Neural mobilization
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.
PNF hold relax technique
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.

Locations

Country Name City State
Pakistan Holly Family Hospital Rawalpindi

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline
Primary 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. 3 weeks
Primary 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. 6 weeks
Primary 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. baseline
Primary 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. 3 weeks
Primary 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. 6 weeks
Primary 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. baseline
Primary 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. 3 weeks
Primary 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. 6 weeks
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