NCT06397170

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

4 months

First QC Date

April 29, 2024

Last Update Submit

September 12, 2024

Conditions

Keywords

StrokeUpper Extremity ParesisMotor Activity

Outcome Measures

Primary Outcomes (2)

  • 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. higher the score greater is the improvement

    6 months

  • 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. higher the score greater is the improvement

    6 months

Study Arms (2)

Graded repetitive arm supplementary program group

EXPERIMENTAL

Patients in Group A will receive Graded repetitive arm supplementary program.

Other: Graded repetitive arm supplementary program

Task based training group

ACTIVE COMPARATOR

Patients in Group B will receive Task based training.

Other: Task based training

Interventions

Patients in Group A will receive Graded repetitive arm supplementary program

Graded repetitive arm supplementary program group

Patients in Group B will receive Task based training.

Task based training group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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+.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imran International Amjad

Islamabad, Punjab Province, 44000, Pakistan

Location

Related 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.

    PMID: 24505098BACKGROUND
  • 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.

    PMID: 24505342BACKGROUND
  • 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.

    PMID: 33682872BACKGROUND
  • 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.

    PMID: 32176674BACKGROUND

MeSH Terms

Conditions

StrokeParesisMotor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Zeest hashmi

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be divided into Group A (N=19) will receive Graded repetitive arm supplementary program and Patients in Group B (N=19)will receive Task based training.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2024

First Posted

May 2, 2024

Study Start

May 1, 2024

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations