NCT06428201

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.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 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

September 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 24, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

May 24, 2024

Status Verified

May 1, 2024

Enrollment Period

7 months

First QC Date

May 20, 2024

Last Update Submit

May 20, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Montreal Cognitive Assessment (MoCA) scale

    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.

    12 Months

Study Arms (2)

Control Group

ACTIVE COMPARATOR
Diagnostic Test: Control Group

EXP group

EXPERIMENTAL
Combination Product: Experimental Group

Interventions

Control GroupDIAGNOSTIC_TEST

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.

Control Group
Experimental GroupCOMBINATION_PRODUCT

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.

EXP group

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

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

Study Record Dates

First Submitted

May 20, 2024

First Posted

May 24, 2024

Study Start

September 1, 2023

Primary Completion

April 1, 2024

Study Completion

September 1, 2024

Last Updated

May 24, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations