NCT05379998

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
2 days until next milestone

Study Start

First participant enrolled

May 20, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2022

Completed
Last Updated

November 28, 2022

Status Verified

November 1, 2022

Enrollment Period

6 months

First QC Date

May 13, 2022

Last Update Submit

November 24, 2022

Conditions

Keywords

Neural mobilizationPNF hold relaxstroke

Outcome Measures

Primary Outcomes (9)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Group A(neural mobilization)

EXPERIMENTAL

sciatic nerve mobilization(sliding technique)

Other: Neural mobilization

Group B(PNF hold relax)

EXPERIMENTAL

PNF hold relax technique of Hamstring muscle

Other: PNF hold relax technique

Interventions

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.

Group A(neural mobilization)

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.

Group B(PNF hold relax)

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holly Family Hospital

Rawalpindi, Pakistan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Imran Amjad, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This will be a single blinded study. The data will be coded and the analyst will also be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2022

First Posted

May 18, 2022

Study Start

May 20, 2022

Primary Completion

November 20, 2022

Study Completion

November 20, 2022

Last Updated

November 28, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations