- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05506826
Effects of Mirror Therapy Versus Fine Motor Activities on Hand Function in Chronic Stroke Patients.
November 8, 2022 updated by: Riphah International University
to compare the effects of the Mirror therapy and fine motor activities on hand function in chronic stroke patients
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Fedral
-
Islamabad, Fedral, Pakistan, 44000
- Riphah International University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: fine motor activities group
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
|
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
|
Active Comparator: control group
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
fugl mayer assessment FMA upper limb
Time Frame: 9 months
|
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
|
9 months
|
The Functional Independence Measure (FIM)
Time Frame: 9 months
|
The Functional Independence Measure (FIM) is a non-diagnostic disability assessment instrument that was developed for a wide range of groups
|
9 months
|
The Wolf Motor Function Test (WMFT)
Time Frame: 9 months
|
The Wolf Motor Function Test (WMFT) uses timed and functional tasks to assess upper limb motor skills
|
9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Review.
- 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. Review.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2022
Primary Completion (Actual)
August 20, 2022
Study Completion (Actual)
August 20, 2022
Study Registration Dates
First Submitted
August 17, 2022
First Submitted That Met QC Criteria
August 17, 2022
First Posted (Actual)
August 18, 2022
Study Record Updates
Last Update Posted (Actual)
November 9, 2022
Last Update Submitted That Met QC Criteria
November 8, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Neuromuscular Manifestations
- Stroke
- Ischemic Stroke
- Muscle Weakness
- Acute Pain
Other Study ID Numbers
- REC/RCR & AHS/21/0254
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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