Graded Repetitive Arm Supplementary Program Versus Task Based Training on Upper Limb Function in Stroke Patients

September 12, 2024 updated by: Riphah International University

Effects of Graded Repetitive Arm Supplementary Program Versus Task Based Training on Upper Limb Function in Stroke Patients

To determine effects of graded repetitive arm supplementary program versus Task based training on Upper limb function in stroke patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study will be Randomized Clinical Trial. A total of 38 stroke patients will be recruited by using non-probability convenience sampling Technique. Patients will be Randomized and allocated into two interventional groups based on the inclusion and exclusion criteria. Patients in Group A will receive Graded repetitive arm supplementary program and Patients in Group B will receive Task based training. All participants will receive the treatment for 40 minutes per session, 5 days per week for 5 weeks. For the evaluation of all participant scales like be Chedoke Arm and Hand Activity Inventory for clinical relevance, Fugl Mayer assessment scale for performance assessment, Action Reach Arm Test for coordination and dexterity and Motor Activity Log for functional assessment of Upper limb in stroke patients. D

Study Type

Interventional

Enrollment (Actual)

38

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

  • Pakistan
    • Punjab
      • Islamabad, Punjab, Pakistan, 44000
        • Imran International Amjad

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with Sub acute stage of stroke.
  • Patients with Ischemic and Haemorrhagic stroke.
  • Patients with Cognition level on Mini Mental State Examination must be > 24
  • Patients with mild pain in upper extremity according to Numeric Pain Rating Scale
  • Patients with Grade 2 active movements in affected extremity Tone of upper limb at Modified Ashworth Scale Grade 1+.

Exclusion Criteria:

  • Other neurological disorders e.g. brain tumor, encephalitis, meningitis, brain abscess.
  • Use of antipsychotics
  • Use of drugs for spasticity.
  • Patients with vestibular impairment.

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: Graded repetitive arm supplementary program group
Patients in Group A will receive Graded repetitive arm supplementary program.
Other: Graded repetitive arm supplementary program
Patients in Group A will receive Graded repetitive arm supplementary program
Active Comparator: Task based training group
Patients in Group B will receive Task based training.
Other: Task based training
Patients in Group B will receive Task based training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl Mayer assessment scale
Time Frame: 6 months
It is designed to assess reflex activity, movement control and muscle strength in the upper extremity of people with post-stroke hemiplegia. total score is 126.This tool has an excellent Inter- and intrarater reliability (intra class correlation coefficient = 0.98-0.99), validity is also excellent (r = 0.74-0.93, P < .0001). Higher scores indicate maximum recovery. higher the score greater is the improvement
6 months
The Motor Activity Log (MAL)
Time Frame: 6 months
The Motor Activity Log (MAL) is a subjective outcome measure of an individual's real life functional upper limb performance. The Motor activity log is administered by semi-structured interview and items are scored by patients according to their performance of each task over the past 7 days. The MAL adopts a 6-point ordinal scale, although patients can attribute a half-score, resulting in 11-point Likert scales with specified anchoring definitions at 6 points. higher the score greater is the improvement
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Zeest hashmi, Riphah International University

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

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)

May 1, 2024

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

September 1, 2024

Study Registration Dates

First Submitted

April 29, 2024

First Submitted That Met QC Criteria

April 29, 2024

First Posted (Actual)

May 2, 2024

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 12, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/23/0281

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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