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Comparison of TSTVs NT Along With Conventional Therapy for Upper Limb Motor Function Among Chronic Stroke Patients

Primary Purpose

Stroke

Status
Active
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Task Specific Training
Neurodevelopmental Training
Sponsored by
Superior University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic ischemic stroke patients( after 3 months of stroke ).(41)
  • Patients from both gender.(42)
  • Patients of around age of 45-65.(43)
  • Patient with limb spasticity equal to 2 or less than 2 on modified ash worth scale.(44)
  • Patient with good cognitive function minimum 20 or more on Mini Mental State Examination (MMSE).(45)

Exclusion Criteria:

  • Patients with history of the recurrent stroke.(41)
  • Patient with fracture or dislocation of upper limb.(46)
  • Patient with any peripheral vascular disease (47)
  • Patient with any comorbid neurological disease like Parkinsonism, epilepsy, multiple sclerosis and spinal cord injury.(21)
  • Patient with skin discoloration, skin ulcers and skin allergy.(48)

Sites / Locations

  • Shadman Medical Centre Chaudhry Muhammad Akram Teaching and Research Hospital University of Lahore Teaching Hospital Services Hospital Lahore General Hospital Bashir Neuro Supine Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Task Specific Training

Neurodevelopmental Training

Arm Description

Using Task Specific Training

Using Neurodevelopmental Training

Outcomes

Primary Outcome Measures

Neurodevelopmental Training
37 will receive Neurodevelopmental treatment is based on the premise that the presence of normal postural reflex mechanisms is fundamental to a motor skill's performance. Mini mental state examination test

Secondary Outcome Measures

Task Specific Training
37 will receive Task specific training is a type of exercise treatment involving repeated practise with your affected arm/hand. Wolf Motor Function Test (WMFT)

Full Information

First Posted
May 10, 2022
Last Updated
June 6, 2022
Sponsor
Superior University
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1. Study Identification

Unique Protocol Identification Number
NCT05397366
Brief Title
Comparison of TSTVs NT Along With Conventional Therapy for Upper Limb Motor Function Among Chronic Stroke Patients
Official Title
Comparison of Task Specific Training Vs Neurodevelopmental Training Along With Conventional Therapy for Upper Limb Motor Function Among Chronic Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Superior University

4. Oversight

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

5. Study Description

Brief Summary
Comparison of Task Specific Training Vs Neurodevelopmental Training Along with Conventional Therapy for Upper Limb Motor Function Among Chronic Stroke Patients
Detailed Description
To compare Task Specific Training versus Neurodevelopmental Training along with conventional therapy for upper limb motor function among chronic stroke patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Task Specific Training
Arm Type
Experimental
Arm Description
Using Task Specific Training
Arm Title
Neurodevelopmental Training
Arm Type
Experimental
Arm Description
Using Neurodevelopmental Training
Intervention Type
Diagnostic Test
Intervention Name(s)
Task Specific Training
Intervention Description
Group A will be given Task Specific protocol with routine physical therapy treatment for 45 mins on the upper limb for 3 days a week for a period of 12 weeks. This Task Specific protocol will include different exercises like, do the polishing of the table top , can perform arm cradling, can supinate and pronate the cylindrical object with arm , while pushing the cylindrical object can extend the wrist , can reach forward to touch or to pick an object , can bend side ways to pick the object and place it on the table in front , can pour the 1/2cup of water to the wide jar that is held by the patient in other hand , patient can comb his hair , patient can drink and eat independently , can lift the jar and bring it close to lips , can pick up pen by using thumb and two fingers , can do the stacking checkers , can throw a ball into the basket , can push the ball on wall from front and side.
Intervention Type
Diagnostic Test
Intervention Name(s)
Neurodevelopmental Training
Intervention Description
Group B will receive the Neurodevelopmental protocol with the routine physical therapy for 45 mins on the upper limb 3 times a week for period of 12 weeks. The intervention will be performed by the trained physical therapist. This Neurodevelopmental protocol will include different exercises like , patient should sit while bearing weight , patient can do self-overhead movements with hand clasped , while holding the gymnastic ball reach forward and overhead position while sitting , weight bearing while plantigrade or quadruped position , while sitting or standing can move the ball in forward , backward and sideways.
Primary Outcome Measure Information:
Title
Neurodevelopmental Training
Description
37 will receive Neurodevelopmental treatment is based on the premise that the presence of normal postural reflex mechanisms is fundamental to a motor skill's performance. Mini mental state examination test
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Task Specific Training
Description
37 will receive Task specific training is a type of exercise treatment involving repeated practise with your affected arm/hand. Wolf Motor Function Test (WMFT)
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic ischemic stroke patients( after 3 months of stroke ).(41) Patients from both gender.(42) Patients of around age of 45-65.(43) Patient with limb spasticity equal to 2 or less than 2 on modified ash worth scale.(44) Patient with good cognitive function minimum 20 or more on Mini Mental State Examination (MMSE).(45) Exclusion Criteria: Patients with history of the recurrent stroke.(41) Patient with fracture or dislocation of upper limb.(46) Patient with any peripheral vascular disease (47) Patient with any comorbid neurological disease like Parkinsonism, epilepsy, multiple sclerosis and spinal cord injury.(21) Patient with skin discoloration, skin ulcers and skin allergy.(48)
Facility Information:
Facility Name
Shadman Medical Centre Chaudhry Muhammad Akram Teaching and Research Hospital University of Lahore Teaching Hospital Services Hospital Lahore General Hospital Bashir Neuro Supine Institute
City
Lahore
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of TSTVs NT Along With Conventional Therapy for Upper Limb Motor Function Among Chronic Stroke Patients

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