NCT06437015

Brief Summary

CIMT vs Mirror therapy for improving hand function in infarcted CVA patients. Randomized clinical trial study design will be followed. Data will be collected from following centers: Minhaj Physiotherapy Centre, Home visits, Sughra sidiq trust hospital, Ibad hospital Samundri. Probability Random Sampling is used.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

November 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2024

Completed
Last Updated

May 31, 2024

Status Verified

May 1, 2024

Enrollment Period

7 months

First QC Date

May 25, 2024

Last Update Submit

May 25, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • The Fugl-Meyer Assessment (FMA)

    it is a stroke-specific, performance-based impairment index.Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully

    12 Months

  • The Chedoke Arm and Hand Activity Inventory (CAHAI)

    It is used to assess functional ability of the paretic arm and hand. This test consists of 13 functional tasks: open a jar of coffee, draw a line with a ruler, put toothpaste on a toothbrush, cut medium consistency putty,pour a glass of water wring out a washcloth,clean a pair of eyeglasses,zip up a zipper,botton up 5 buttons,dry back with a towel,place a container on a table and carry a bag up the stairs.

    12 months

Study Arms (2)

Constraint-Induced Movement Therapy

EXPERIMENTAL
Diagnostic Test: Constraint-Induced Movement Therapy

Mirror Therapy

ACTIVE COMPARATOR
Other: Mirror Therapy

Interventions

patient's unaffected hand is tied with a triangular bandage or splint and the patient asks to perform the exercise through the affected hand. for up to 6 hours a day for 5days week /4 weeks and the patient nonparetic arm restrained from the use by having the patient placing a mitt on the hand or a sling on the unaffected hand, forcing the use of the affected limb to promote purposeful movements when performing functional tasks.

Constraint-Induced Movement Therapy

In this group training was given for 45min a day for 5 days a week for 4 weeks. Mirror box which was of 18×24inch \[was placed on the learning table and exercises were carried out by the patient looking into the mirror where an unaffected limb is placed in front of the mirror, through looking into the mirror patient assumes the reflection of the unaffected limb as the paretic limb. Exercises performed were hand opening and closing, wrist extension and flexion, squeezing, opposition, the calculation

Mirror Therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Infarcted CVA patients
  • Patients with hand improvement needed
  • Patients in recovery stage of stroke from 2 months to 1 year
  • Patients who can participate in 45 mins of session

You may not qualify if:

  • Patients with hand function disturbed due to any other reason except infarcted CVA, - - - Patients with shoulder subluxation and upper limb contractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minhaj Physiotherapy, opp Shalimar Hospital , Shalimar

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Interventions

Mirror Movement Therapy

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 25, 2024

First Posted

May 31, 2024

Study Start

November 1, 2023

Primary Completion

May 20, 2024

Study Completion

October 29, 2024

Last Updated

May 31, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations