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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06397170
Other study ID # REC/RCR & AHS/23/0281
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2024
Est. completion date September 15, 2024

Study information

Verified date June 2024
Source Riphah International University
Contact Zeest hashmi
Phone 03224655851
Email zeest.hashmi@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 38
Est. completion date September 15, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 60 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Pakistan Imran International Amjad Islamabad Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

Connell LA, McMahon NE, Watkins CL, Eng JJ. Therapists' use of the Graded Repetitive Arm Supplementary Program (GRASP) intervention: a practice implementation survey study. Phys Ther. 2014 May;94(5):632-43. doi: 10.2522/ptj.20130240. Epub 2014 Feb 6. — View Citation

Lee HS, Lim JH, Jeon BH, Song CS. Non-immersive Virtual Reality Rehabilitation Applied to a Task-oriented Approach for Stroke Patients: A Randomized Controlled Trial. Restor Neurol Neurosci. 2020;38(2):165-172. doi: 10.3233/RNN-190975. — View Citation

Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014. — View Citation

Yang CL, Waterson S, Eng JJ. Implementation and Evaluation of the Virtual Graded Repetitive Arm Supplementary Program (GRASP) for Individuals With Stroke During the COVID-19 Pandemic and Beyond. Phys Ther. 2021 Jun 1;101(6):pzab083. doi: 10.1093/ptj/pzab083. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Fugl Mayer assessment scale 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 6 months
Primary The Motor Activity Log (MAL) 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 6 months
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