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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05473390
• Other study ID #: on posture & Balance
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2022
• Est. completion date: October 2023

Study information

• Verified date: January 2023
• Source: Beni-Suef University
• Contact: mohammed yo elhamrawy, phd
• Phone: 002 01282805567
• Email: dr_melhamrawy[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemiplegia
• Stroke

Intervention

Other:
• functional electrical stimulation
functional electrical stimulation on back muscles
• kinesotaping
no intervention

Locations

Country	Name	City	State
Egypt	National institute for Gerontology	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	spinal posture	3 D assessment of spinal posture using Microsoft kinect	"up to 8 weeks"
Primary	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)	"up to 8 weeks"