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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06108440
Other study ID # REC/RCR & AHS/23/0232
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 3, 2023
Est. completion date February 1, 2024

Study information

Verified date March 2024
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To Compare effects of action observation and motor imagery training on upper limb function in chronic stroke patients.


Description:

The study is Randomized controlled trial. The study will be conducted on 44 stroke patients. The study will be conducted in Civil Hospital Shujaabad and Riphah rehabilitation centre Lahore. Patients will be divided into Group A (n = 20) and Group B (n = 20) using a randomization through computer generated numbers program. Patients in Group A will receive action observation training with conventional treatment. All participants will undergo the training for 25 minutes per session, 5 days per week for 8 weeks. Patients in Group B will receive motor imagery with conventional treatment. All participants will receive interventions for twenty-five minutes per session, five times a week, for eight weeks. For the pre- and post-evaluation of all participants, Fugl-Meyer Assessment Upper Extremity (FMA UE) and Wolf Motor Function Test (WMFT) will be used. Data will be analyzed by using SPSS (Statistical package for Social Sciences) 25 version.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date February 1, 2024
Est. primary completion date February 1, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria: - Diagnosed with chronic stroke by a neurologist - 03 months post stroke - Score 1+ on modified ashworth scale - Having a score of 24 or higher in the Mini-Mental State Examination Exclusion Criteria: - Patient with neurological condition other than stroke e.g. Parkinson's or multiple sclerosis - Presence of an attached artificial pacemaker - Presence of a metal implant in the brain - Presence of visual impairment - Presence of unilateral neglect in Line bisection test (25) - Use of antipsychotic drugs

Study Design


Intervention

Other:
action observation training
Patients in Group A will receive action observation training with conventional treatment. All participants will undergo the training for 25 minutes per session, 5 days per week for 8 weeks.
motor imagery training
Patients in Group B will receive motor imagery with conventional treatment. All participants will receive interventions for twenty-five minutes per session, five times a week, for eight weeks.

Locations

Country Name City State
Pakistan Riphah International University Lahore Fedral

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

Demartino AM, Rodrigues LC, Gomes RP, Michaelsen SM. Hand function and type of grasp used by chronic stroke individuals in actual environment. Top Stroke Rehabil. 2019 May;26(4):247-254. doi: 10.1080/10749357.2019.1591037. Epub 2019 Mar 23. — View Citation

Kuriakose D, Xiao Z. Pathophysiology and Treatment of Stroke: Present Status and Future Perspectives. Int J Mol Sci. 2020 Oct 15;21(20):7609. doi: 10.3390/ijms21207609. — View Citation

Serlin Y, Shelef I, Knyazer B, Friedman A. Anatomy and physiology of the blood-brain barrier. Semin Cell Dev Biol. 2015 Feb;38:2-6. doi: 10.1016/j.semcdb.2015.01.002. Epub 2015 Feb 11. — View Citation

Veldema J, Nowak DA, Gharabaghi A. Resting motor threshold in the course of hand motor recovery after stroke: a systematic review. J Neuroeng Rehabil. 2021 Nov 3;18(1):158. doi: 10.1186/s12984-021-00947-8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Fugl-Meyer Assessment Upper Extremity (FMA UE): Fugl-Meyer Assessment Upper Extremity (FMA UE):
FMA UE is a detailed evaluation tool that quantitatively measures motor function, balance, sensation, joint range of motion, and pain in stroke hemiplegic patients
6 months
Primary Wolf Motor Function Test (WMFT): Wolf Motor Function Test (WMFT):
The Wolf motor function test is a tool to evaluate upper extremity motor function in hemiplegic patients. It has 17 tasks with a score range from 0-5. The inter-rater reliability of the function score is 0.88 and the inter-rated reliability of performance time is 0.97
6 months
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