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

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

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: functional electrical stimulation; Other: kinesotaping

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mohammed yo elhamrawy, phd; Phone Number: 002 01282805567; Email: dr_melhamrawy@yahoo.com
• Study Contact Backup: Name: mohammed s saif, phd; Phone Number: 002 01223456757

Study Locations

• Egypt
  • Cairo, Egypt, 62511
    • Recruiting
    • National institute for Gerontology
    • Contact: Mohamed s Saif, phd; Phone Number: 00201223456757

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: study group; 20 patient with hemiplegia	Other: functional electrical stimulation; functional electrical stimulation on back muscles; Other: kinesotaping; no intervention
Active Comparator: control group; 20 patient with hemiplegia	Other: functional electrical stimulation; functional electrical stimulation on back muscles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
spinal posture	3 D assessment of spinal posture using Microsoft kinect	"up to 8 weeks"
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"

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Principal Investigator: mohammed s Saif, phd, National institute for Gerontology

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2022
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: July 22, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Estimate): January 24, 2023
• Last Update Submitted That Met QC Criteria: January 21, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis; Hemiplegia
• Other Study ID Numbers: on posture & Balance

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No