## Protocol Section
### Identification Module
**NCT ID:** NCT06428201

**Brief Title:** The Efficacy of Tele Rehabilitation- Based Task-Specific Training for Cognitive Function Improvement

**Official Title:** The Efficacy of Tele Rehabilitation- Based Task-Specific Training for Cognitive Function Improvement in Multiple Sclerosis (MS) Patients

#### Organization Study ID Info
**ID:** MSRSW/Batch-Fall22/711
#### Organization
**Class:** OTHER
**Full Name:** Superior University
### Status Module
#### Completion Date
**Date:** 2024-09-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2024-04-01

**Type:** ACTUAL

#### Start Date
**Date:** 2023-09-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### 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:** "This study investigates the feasibility of tele-rehabilitation combined with targeted training for cognitive enhancement in individuals with Multiple Sclerosis (MS). Multiple sclerosis (MS) is a chronic illness that affects the central nervous system, often resulting in cognitive impairments that significantly impact quality of life. Tele-restoration provides an accessible and effective method for delivering therapeutic interventions, particularly beneficial for those with mobility limitations.

**Detailed Description:** The study was a randomized controlled trial with multiple sclerosis patients divided into two groups: one receiving tele-rehabilitation-based task-specific training and the other receiving conventional care. The mediation group participated in structured cognitive training sessions conducted using a tele-rehabilitation platform, focusing on tasks designed to enhance memory, attention, and executive functions. Psychological assessments were conducted during the mediation period to measure improvements.

### Conditions Module

**Conditions:**

- Sclerosis, Multiple

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 52

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Diagnostic Test: Control Group

**Label:** Control Group

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Combination Product: Experimental Group

**Label:** EXP group

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control Group

**Description:** The control group receives standard care, which includes routine medical management and general physical rehabilitation exercises. This involves regular consultations with healthcare providers and exercises aimed at maintaining mobility and physical function. The control group also follows a schedule of three 45-minute sessions per week for 12 weeks, ensuring a consistent comparison with the experimental group.

**Name:** Control Group

**Type:** DIAGNOSTIC_TEST

#### Intervention 2

**Arm Group Labels:**

- EXP group

**Description:** The experimental intervention involves tele-rehabilitation-based task-specific training to enhance cognitive functions in multiple sclerosis (MS) patients. This program includes cognitive exercises targeting memory, attention, executive function, and processing speed, conducted remotely via a tele-rehabilitation platform. Patients participate in three 45-minute sessions per week for 12 weeks. Each session is guided by a trained therapist, ensuring personalized support and real-time feedback.

**Name:** Experimental Group

**Type:** COMBINATION_PRODUCT

### Outcomes Module

#### Primary Outcomes

**Description:** The MoCA scale is a comprehensive tool designed to evaluate various cognitive domains, including attention and concentration, executive functions, memory, language, visuospatial skills, conceptual thinking, calculations, and orientation. It provides a detailed assessment of cognitive performance, making it an ideal measure for tracking cognitive improvements in MS patients participating in the tele-rehabilitation and task-specific training programs.

**Measure:** Montreal Cognitive Assessment (MoCA) scale

**Time Frame:** 12 Months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Individuals with a diagnosis of MS confirmed by a neurologist.
* Between 18 and 65 years of age.
* Presence of psychosis confirmed by standardized psychometric testing.
* A stable treatment environment that allows intervention.
* Internet access with camera and computer/tablet.
* Ability to understand and follow course directions.
* Willingness to give informed consent.

Exclusion Criteria:

* Severe psychiatric co-morbidities affecting cognitive function.
* Concurrent intervention with other psychological rehabilitation programs.
* Lack of availability or use of technology necessary for tele-rehabilitation.
* Further research interventions.
* Unstable medical condition

**Maximum Age:** 45 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Lahore

**Country:** Pakistan

**Facility:** District Head Quarters Hospital Narowal, Circular Road, Near Jassar Bypass, Narowal Location: Khalid Eye & Medical Care Block C Commercial Area, Jubilee Town, Lahore

**State:** Punjab

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000020278

- Term: Demyelinating Autoimmune Diseases, CNS

- ID: D000020274

- Term: Autoimmune Diseases of the Nervous System

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000003711

- Term: Demyelinating Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M15415

- Name: Sclerosis

- Relevance: HIGH

- As Found: Sclerosis

- ID: M12060

- Name: Multiple Sclerosis

- Relevance: HIGH

- As Found: Sclerosis, Multiple

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22098

- Name: Demyelinating Autoimmune Diseases, CNS

- Relevance: LOW

- As Found: Unknown

- ID: M22094

- Name: Autoimmune Diseases of the Nervous System

- Relevance: LOW

- As Found: Unknown

- ID: M6909

- Name: Demyelinating Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009103

- Term: Multiple Sclerosis

- ID: D000012598

- Term: Sclerosis

### Misc Info Module

- Version Holder: 2024-05-31
