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Effects of Mirror Therapy Versus Fine Motor Activities on Hand Function in Chronic Stroke Patients.

Primary Purpose

Stroke, Ischemic, Acute Pain, Weakness, Muscle

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
fine motor activities
conventional therapy and mirror therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic focused on measuring Stroke, Ischemic, Acute Pain, Weakness, Muscle

Eligibility Criteria

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

Inclusion Criteria:

  • A score greater than 24 on the Mini-Mental State examination test
  • Chronic stroke patients whose episode of stroke onset was 6 months to 2 years.
  • Patients who are able to communicate well and grasp the therapist's spoken instructions

Exclusion Criteria:

  • Patients who have restricted joint movement in their healthy upper extremities.
  • Neglect syndrome or a visual field deficiency
  • Patients with recurrent stroke.
  • Spine surgery.

Sites / Locations

  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

fine motor activities group

control group

Arm Description

Patients in this group will receive conventional therapy for 1 month sixty minutes/day, 5 days/week in addition to performing fine motor exercises like therapy ball exercises, therapy putty exercises, table top exercises, moving beans, stacking pennies and rubber band resistances exercises etc. for 30 minutes

Patients in this group will receive conventional therapy for four weeks sixty minutes per day, five days per week. In addition, receive thirty minutes of mirror therapy, which included periodic wrist flexion-extension, flexion and extension exercises of fingers on non paralyzed limb

Outcomes

Primary Outcome Measures

fugl mayer assessment FMA upper limb
For stroke patients, the Fugal-Meyer Assessment (FMA) is a performance-based impairment measure. It is used to assess balance, motor function, sensation, and joint function in persons who suffer hemiplegia after a stroke. In both clinical and research settings, it is used to identify sickness severity, define motor recovery, and plan and assess treatment
The Functional Independence Measure (FIM)
The Functional Independence Measure (FIM) is a non-diagnostic disability assessment instrument that was developed for a wide range of groups
The Wolf Motor Function Test (WMFT)
The Wolf Motor Function Test (WMFT) uses timed and functional tasks to assess upper limb motor skills

Secondary Outcome Measures

Full Information

First Posted
August 17, 2022
Last Updated
November 8, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05506826
Brief Title
Effects of Mirror Therapy Versus Fine Motor Activities on Hand Function in Chronic Stroke Patients.
Official Title
Effects of Mirror Therapy Versus Fine Motor Activities on Hand Function in Chronic Stroke Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
August 20, 2022 (Actual)
Study Completion Date
August 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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
to compare the effects of the Mirror therapy and fine motor activities on hand function in chronic stroke patients
Detailed Description
This study will be conducted to compare the effects of mirror therapy and fine motor activities in chronic stroke patients. Total Twenty eight hemiplegic patients will be recruited according to inclusion criteria and data will be collected from Riphah rehabilitation centre Lahore and Mian Munshi Hospital Lahore (DHQ). The patients will randomly assigned to a mirror therapy group (n=14) and Fine motor activities group (n=14). The patients in both groups will undergo conventional therapy for 4 weeks (60minutes/day, 5 days/week). The patients will be evaluated at the beginning and end of the treatment by Fugl- Meyer Aassessment (FMA) wolf motor assessment scale and the Functional Independence Measure (FIM). After approval from ethical committee, data collection will be started and informed consent will be taken from all patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic, Acute Pain, Weakness, Muscle
Keywords
Stroke, Ischemic, Acute Pain, Weakness, Muscle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study participants will be divided in two groups. Patients in group A will receive conventional therapy for four weeks sixty minutes per day, five days per week. In Group B patients will perform fine motor exercises like therapy ball exercises, therapy putty exercises, table top exercises, moving beans, stacking pennies and rubber band resistances exercises etc. for 30 minutes along with conventional therapy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fine motor activities group
Arm Type
Experimental
Arm Description
Patients in this group will receive conventional therapy for 1 month sixty minutes/day, 5 days/week in addition to performing fine motor exercises like therapy ball exercises, therapy putty exercises, table top exercises, moving beans, stacking pennies and rubber band resistances exercises etc. for 30 minutes
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Patients in this group will receive conventional therapy for four weeks sixty minutes per day, five days per week. In addition, receive thirty minutes of mirror therapy, which included periodic wrist flexion-extension, flexion and extension exercises of fingers on non paralyzed limb
Intervention Type
Other
Intervention Name(s)
fine motor activities
Intervention Description
patient will perform fine motor exercises like therapy ball exercises, therapy putty exercises, table top exercises, moving beans, stacking pennies and rubber band resistances exercises etc. for 30 minutes along with conventional therapy
Intervention Type
Other
Intervention Name(s)
conventional therapy and mirror therapy
Intervention Description
Patients in this group will receive conventional therapy for four weeks sixty minutes per day, five days per week. In addition, receive thirty minutes of mirror therapy, which included periodic wrist flexion-extension, flexion and extension exercises of fingers on non paralyzed limb
Primary Outcome Measure Information:
Title
fugl mayer assessment FMA upper limb
Description
For stroke patients, the Fugal-Meyer Assessment (FMA) is a performance-based impairment measure. It is used to assess balance, motor function, sensation, and joint function in persons who suffer hemiplegia after a stroke. In both clinical and research settings, it is used to identify sickness severity, define motor recovery, and plan and assess treatment
Time Frame
9 months
Title
The Functional Independence Measure (FIM)
Description
The Functional Independence Measure (FIM) is a non-diagnostic disability assessment instrument that was developed for a wide range of groups
Time Frame
9 months
Title
The Wolf Motor Function Test (WMFT)
Description
The Wolf Motor Function Test (WMFT) uses timed and functional tasks to assess upper limb motor skills
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A score greater than 24 on the Mini-Mental State examination test Chronic stroke patients whose episode of stroke onset was 6 months to 2 years. Patients who are able to communicate well and grasp the therapist's spoken instructions Exclusion Criteria: Patients who have restricted joint movement in their healthy upper extremities. Neglect syndrome or a visual field deficiency Patients with recurrent stroke. Spine surgery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zeest hashmi, MSNMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Islamabad
State/Province
Fedral
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32363957
Citation
Hillis AE. Developments in treating the nonmotor symptoms of stroke. Expert Rev Neurother. 2020 Jun;20(6):567-576. doi: 10.1080/14737175.2020.1763173. Epub 2020 May 12.
Results Reference
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PubMed Identifier
32103968
Citation
Gandhi DB, Sterba A, Khatter H, Pandian JD. Mirror Therapy in Stroke Rehabilitation: Current Perspectives. Ther Clin Risk Manag. 2020 Feb 7;16:75-85. doi: 10.2147/TCRM.S206883. eCollection 2020.
Results Reference
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PubMed Identifier
31777474
Citation
Umeki N, Murata J, Higashijima M. Effects of Training for Finger Perception on Functional Recovery of Hemiplegic Upper Limbs in Acute Stroke Patients. Occup Ther Int. 2019 Nov 4;2019:6508261. doi: 10.1155/2019/6508261. eCollection 2019.
Results Reference
background
PubMed Identifier
30792371
Citation
Fong KNK, Ting KH, Chan CCH, Li LSW. Mirror therapy with bilateral arm training for hemiplegic upper extremity motor functions in patients with chronic stroke. Hong Kong Med J. 2019 Feb;25 Suppl 3(1):30-34. No abstract available.
Results Reference
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Effects of Mirror Therapy Versus Fine Motor Activities on Hand Function in Chronic Stroke Patients.

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