FES VS Constrained Induced MT Recovery and Spasticity in... | NCT05854121

Studies
FES VS Constrained Induced MT Recovery and Spasticity in Upper Limb Hemiparetic Ischemic Patients

NCT05854121

Sponsor

Superior University

Status

Unknown status

Last Update Posted

May 11, 2023Actual

Enrollment

56Estimated

Phase

Not Applicable

Conditions

Stroke

Interventions

Functional Electrical Stimulation
Constrained Induced Movement Therapy

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 10, 2023

First Posted Date

May 11, 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 10, 2023

Last Update Posted Date

May 11, 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 determines the effects of Functional Electrical Stimulation versus Constrained Induced Movement Therapy for motor recovery and spasticity in Upper Limb Hemiparetic 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

56Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Functional Electrical Stimulation	Other		Diagnostic Test: Functional Electrical Stimulation
Constrained Induced Movement Therapy	Experimental		Diagnostic Test: Constrained Induced Movement Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Functional Electrical Stimulation	Diagnostic Test	Functional Electrical Stimulation for Motor Recovery and Spasticity in Upper Limb Hemiparetic Chronic Ischemic Stroke Patients	Functional Electrical Stimulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Scale Modified Ash worth		6 Months
Motor Function assessment test		6 Months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinically diagnosed chronic ischemic stroke patients. Patients from both genders Age 45 year and older. Patients having upper limb spasticity equal to 2 or less than 2 according to modified ash worth scale.

Patients having active cognitive scoring on Mini Mental State Examination.

Exclusion Criteria:

Having pacemaker and other stimulation devices. Prosthesis of bones, joints in targeted region of treatment. Patients presenting the history of recurrent stroke. Patients having history of bilateral hemiparesis. Co-morbid history of tumor, heart disease, hypertensive. Patients presenting with skin lesions, wounds, discoloration will be excluded from this research.

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
Salwa Jamil, DPT	Contact	+923209458491		Salwajamil998@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shadman Medical Care	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