Effect of FES of Interscapular Muscles on Spinal Posture and Balance in Elderly Hemiplegic Patients

• Sponsor: Beni-Suef University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05473390
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8.5
• Patients Per Site Per Month: 4.7

Study Details

Study Description

Brief Summary

Stroke patients 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

Condition or Disease	Intervention/Treatment	Phase
Stroke	Other: functional electrical stimulation; Other: kinesotaping	N/A

Detailed Description

To evaluate whether the application of FES of the intrascapular muscles in chronic stroke patients affect spinal posture and/or balance.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Combined Muscle Energy Technique and Kineso Taping Effect on Spinal Posture and Balance in Elderly Hemiparetic Patients
• Actual Study Start Date: Jan 15, 2022
• Anticipated Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: study group 20 patient with hemiplegia, minimum 6 months post stroke	Other: functional electrical stimulation; functional electrical stimulation on intrascapular muscles; Other: kinesotaping; kinesotaping for intrascapular muscles
Active Comparator: control group 20 patient with hemiplegia, minimum 6 months post stroke	Other: functional electrical stimulation; functional electrical stimulation on intrascapular muscles

Outcome Measures

Primary Outcome Measures

1. spinal posture ["up to 8 weeks"]

   3 D assessment of spinal posture using Microsoft kinect

2. Balance assessment ["up to 8 weeks"]

   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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National institute for Gerontology	Banī Suwayf	Bani Suwayf	Egypt	62511

Sponsors and Collaborators

• Beni-Suef University

Investigators

• Principal Investigator: mohammed elhamrawy, PHD, national institute for longevity elderly sciences, Beni Suef University, Egypt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohammed Youssef Elhamrawy, Principal Investigator, Beni-Suef University
• ClinicalTrials.gov Identifier: NCT05473390
• Other Study ID Numbers: FES on posture & Balance
• First Posted: Jul 25, 2022
• Last Update Posted: Aug 16, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 16, 2022