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Effect of FES of Back Muscles on Spinal Posture and Gait in Hemiplegia

Primary Purpose

Stroke

Status

Recruiting

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

functional electrical stimulation

kinesotaping

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

1 Year - 10 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

60 years and above with stroke > 6 months ago
people living independently (not community dwelling, hospitals, nurse homes etc)
moving and performing daily activities independently
no problems in terms of verbal communication
no physical and cognitive restrictions.

Exclusion Criteria:

Having cognitive impairment as tested by the Mini-Mental State Examination (with scores < 24)
Uncontrolled hypertension (systolic blood pressure > 160 mmHg)
Joint replacement
Incontinence

Sites / Locations

National institute for GerontologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

study group

control group

Arm Description

20 patient with hemiplegia

Outcomes

Primary Outcome Measures

spinal posture

3 D assessment of spinal posture using Microsoft kinect

Balance assessment

balance assessment using Time up and go test TUG high risk (>13.5 seconds): ____ None/low/moderate: (<13.5 seconds) and Berg scale normal score for elderly (45:56)

Secondary Outcome Measures

Full Information

NCT ID

NCT05473390

First Posted

July 21, 2022

Last Updated

January 21, 2023

Sponsor

Beni-Suef University

1. Study Identification

Unique Protocol Identification Number

NCT05473390

Brief Title

Effect of FES of Back Muscles on Spinal Posture and Gait in Hemiplegia

Official Title

Effect of FES of Back Muscles on Spinal Posture and Gait in Hemiplegia

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 15, 2022 (Actual)

Primary Completion Date

April 30, 2023 (Anticipated)

Study Completion Date

October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beni-Suef University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Hemiplegic patient have unbalanced posture because paralysis leads to muscle atrophy, which then causes an unbalanced alignment in the structure of spinal joints. Evaluation and therapy of postural alignment are important as early predictable factors in the overall daily function of stroke patients

Detailed Description

To evaluate whether the application of FES of the back muscles in hemiplegic affect spinal posture and/or gait

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

study group

Arm Type

Active Comparator

Arm Description

20 patient with hemiplegia

Arm Title

control group

Arm Type

Active Comparator

Arm Description

20 patient with hemiplegia

Intervention Type

Other

Intervention Name(s)

functional electrical stimulation

Intervention Description

functional electrical stimulation on back muscles

Intervention Type

Other

Intervention Name(s)

kinesotaping

Intervention Description

no intervention

Primary Outcome Measure Information:

Title

spinal posture

Description

3 D assessment of spinal posture using Microsoft kinect

Time Frame

"up to 8 weeks"

Title

Balance assessment

Description

balance assessment using Time up and go test TUG high risk (>13.5 seconds): ____ None/low/moderate: (<13.5 seconds) and Berg scale normal score for elderly (45:56)

Time Frame

"up to 8 weeks"

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 20 children with c.p. hemiplegia moving and performing daily activities independently no problems in terms of verbal communication no physical and cognitive restrictions. Exclusion Criteria: Having cognitive impairment as tested by the Mini-Mental State Examination (with scores < 24) Uncontrolled hypertension (systolic blood pressure > 160 mmHg) Joint replacement Incontinence

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

mohammed yo elhamrawy, phd

Phone

002 01282805567

dr_melhamrawy@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

mohammed s saif, phd

Phone

002 01223456757

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

mohammed s Saif, phd

Organizational Affiliation

National institute for Gerontology

Official's Role

Principal Investigator

Facility Information:

Facility Name

National institute for Gerontology

City

Cairo

ZIP/Postal Code

62511

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mohamed s Saif, phd

Phone

00201223456757

12. IPD Sharing Statement

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Effect of FES of Back Muscles on Spinal Posture and Gait in Hemiplegia

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