Comparison of Tele-rehabilitation Versus In-clinic Rehabilitation for Upper Limb Motor Function Stroke Patients

Sponsor

Superior University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05875818

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

13.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine the effects of Tele-rehabilitation versus in-clinical rehabilitation for upper limb motor function and spasticity in chronic ischemic stroke patients.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Diagnostic Test: In-clinic Rehabilitation Diagnostic Test: Tele-rehabilitation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Comparison of Effects of Tele-rehabilitation Versus In-clinic Rehabilitation for Upper Limb Motor Function in Chronic Stroke Patients

Actual Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Tele-rehabilitation	Diagnostic Test: Tele-rehabilitation Effects of Tele-rehabilitation for Upper Limb Motor Function in Chronic Stroke Patients
Experimental: In-clinic Rehabilitation	Diagnostic Test: In-clinic Rehabilitation Effects of In-clinic Rehabilitation for Upper Limb Motor Function in Chronic Stroke Patients

Arm

Intervention/Treatment

Other: Tele-rehabilitation

Diagnostic Test: Tele-rehabilitation

Effects of Tele-rehabilitation for Upper Limb Motor Function in Chronic Stroke Patients

Experimental: In-clinic Rehabilitation

Diagnostic Test: In-clinic Rehabilitation

Effects of In-clinic Rehabilitation for Upper Limb Motor Function in Chronic Stroke Patients

Outcome Measures

Primary Outcome Measures

Fugal Myer assessment scale (FMAS) [6 Months]
Fugal Myer assessment scale (FMAS) to check the pain and funcationality in stroke
Modified Ashworth Scale (MAS) [6 Months]
Modified Ashworth Scale (MAS) to check the pain and funcationality in stroke

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

• Patients from both genders.
Patients with chronic ischemic stroke i.e. 6 months or more.
Patients with 45 years old and above.
On modified Ashworth scale, patient with limb spasticity equal to 2 or less than

On Mini Mental State Examination (MMSE), patients with good cognitive function minimum 24 or more.

Exclusion Criteria:

• Patients with any recurrent stroke history.
Cognitive deficit patients (on Folstein Mini Mental state Examination score of less than 24)
Patient having other neurological diseases.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chaudary Muhammad Akram Teaching Hospital	Lahore	Punjab	Pakistan

Sponsors and Collaborators

Superior University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Muhammad Naveed Babur, Principal Investigator, Superior University

ClinicalTrials.gov Identifier:

NCT05875818

Other Study ID Numbers:

DPT/Batch-Fall18/542

First Posted:

May 25, 2023

Last Update Posted:

May 25, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of May 25, 2023