Comparison of Tele-rehabilitation Versus In-clinic Rehabi... | NCT05875818

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

NCT05875818

Sponsor

Superior University

Status

Unknown status

Last Update Posted

May 25, 2023Actual

Enrollment

68Estimated

Phase

Not Applicable

Conditions

Stroke

Interventions

In-clinic Rehabilitation
Tele-rehabilitation

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2023Actual

Primary Completion Date

Jun 1, 2023Estimated

Completion Date

Aug 31, 2023Estimated

First Submitted Date

Mar 18, 2023

First Submission Date that Met QC Criteria

May 16, 2023

First Posted Date

May 25, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2023

Last Update Posted Date

May 25, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

68Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tele-rehabilitation	Other		Diagnostic Test: Tele-rehabilitation
In-clinic Rehabilitation	Experimental		Diagnostic Test: In-clinic Rehabilitation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
In-clinic Rehabilitation	Diagnostic Test	Effects of In-clinic Rehabilitation for Upper Limb Motor Function in Chronic Stroke Patients	In-clinic Rehabilitation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fugal Myer assessment scale (FMAS)	Fugal Myer assessment scale (FMAS) to check the pain and funcationality in stroke	6 Months
Modified Ashworth Scale (MAS)	Modified Ashworth Scale (MAS) to check the pain and funcationality in stroke	6 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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 2.
- 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hina Riaz, DPT	Contact	+923364795589		dptm-f18-168@superior.edu.pk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chaudary Muhammad Akram Teaching Hospital	Recruiting	Lahore	Punjab Province		Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided