NCT05570461

Brief Summary

This RCT will also help the clinicians to provide the best treatment to their patients for better outcomes. The objective of the study is to determine the efficacy of Modified Constraint-induced movement therapy on the Upper Limb function of Sub-acute stroke patients in Peshawar Pakistan. Alternative Hypothesis: There will be a difference in the means of Modified Constraint-induced movement therapyand traditional physical therapy on the upper limb function of subacute stroke patients.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable stroke

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

November 4, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2023

Completed
Last Updated

October 6, 2022

Status Verified

October 1, 2022

Enrollment Period

9 months

First QC Date

October 3, 2022

Last Update Submit

October 3, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Wolf Motor function test

    Use mainly for post-stroke patients with impaired upper limb motor ability. The purpose of this test is to enumerate upper limb motor ability through a series of functional tasks. The WMFT is an instrument with high internal consistency, interrater reliability and test-retest reliability. The quality of movement during the task is measured by functional ability scale, a 6-point ordinal scale, where 0 = does not attempt with the impaired arm and 5 = arm movement appear to be normal. Higher the value higher will be the normal function.

    4weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

Experimental group will receive Modified Constraint-Induced Movement Therapy and traditional physical therapy to the impaired upper limb based on the repetitive training of functional activities and behavioral shaping and a task-oriented approach, while the unaffected arm of subjects in the Modified Constraint-Induced Movement Therapy group will be constrained by wearing a mitten during the treatment session

Other: Modified Constraint-Induced Movement Therapy

Control Group

ACTIVE COMPARATOR

Control group therapy will consist of increasing upper limb function with the use of both hands. The session include active or active assistive range of motion exercises, unilateral and bimanual activities, balance and strength training or coordination exercises depending on the severity of motor impairment. Similar to group A, daily therapy will be conducted for 40 min/day, 6 days/ week for upto 2 weeks.

Other: Modified Constraint-Induced Movement Therapy

Interventions

Experimental group will receive Modified Constraint-Induced Movement Therapyand traditional physical therapy to the impaired upper limb based on the repetitive training of functional activities and behavioral shaping and a task-oriented approach, while the unaffected arm of subjects in the mCIMT group will be constrained by wearing a mitten during the treatment session and for 3 hours/day outside the therapy hours, 6(six) days/week for two weeks by an experienced Physical therapist.The time duration for Group A will be 40 minutes.

Control GroupExperimental Group

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. Age 30 to 60 years
  • \. Both female \& male will be included.
  • \. Cognitive and lingual ability to communicate with the research staff.
  • \. A minimum of 10 degrees of active finger extension and 20 degrees of active wrist extension(16).
  • \. A history of a single stroke resulting in a hemiparesis

You may not qualify if:

  • \. Recurrent stroke during the training period.
  • \. Neurological or orthopedic disorders prohibiting the use of the paretic arm.
  • \. Patients who doesn't show willingness to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Invistigator

Study Record Dates

First Submitted

October 3, 2022

First Posted

October 6, 2022

Study Start

November 4, 2022

Primary Completion

August 12, 2023

Study Completion

September 25, 2023

Last Updated

October 6, 2022

Record last verified: 2022-10