## Protocol Section
### Identification Module
**NCT ID:** NCT06437015

**Brief Title:** Comparison of CIMT vs Mirror Therapy Effect in Infarcted CVA Patients for Improving Hand Functions

**Official Title:** Comparison of CIMT vs Mirror Therapy Effect in Infarcted CVA Patients for Improving Hand Functions

#### Organization Study ID Info
**ID:** MSRSW/Batch-Fall22/720
#### Organization
**Class:** OTHER
**Full Name:** Superior University
### Status Module
#### Completion Date
**Date:** 2024-10-29

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-25

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-05-20

**Type:** ACTUAL

#### Start Date
**Date:** 2023-11-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-25
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Superior University

#### Responsible Party

**Investigator Affiliation:** Superior University

**Investigator Full Name:** Muhammad Naveed Babur

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Infected Joint

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 26

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Diagnostic Test: Constraint-Induced Movement Therapy

**Label:** Constraint-Induced Movement Therapy

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Other: Mirror Therapy

**Label:** Mirror Therapy

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Constraint-Induced Movement Therapy

**Description:** 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.

**Name:** Constraint-Induced Movement Therapy

**Type:** DIAGNOSTIC_TEST

#### Intervention 2

**Arm Group Labels:**

- Mirror Therapy

**Description:** 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

**Name:** Mirror Therapy

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** The Fugl-Meyer Assessment (FMA)

**Time Frame:** 12 Months

**Description:** 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.

**Measure:** The Chedoke Arm and Hand Activity Inventory (CAHAI)

**Time Frame:** 12 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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

Exclusion Criteria:

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

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Lahore

**Country:** Pakistan

**Facility:** Minhaj Physiotherapy, opp Shalimar Hospital , Shalimar

**State:** Punjab

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
