NCT05473390

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

1.3 years

First QC Date

July 21, 2022

Last Update Submit

January 21, 2023

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

  • 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"

Study Arms (2)

study group

ACTIVE COMPARATOR

20 patient with hemiplegia

Other: functional electrical stimulationOther: kinesotaping

control group

ACTIVE COMPARATOR

20 patient with hemiplegia

Other: functional electrical stimulation

Interventions

functional electrical stimulationOTHER

functional electrical stimulation on back muscles

control groupstudy group
kinesotapingOTHER

no intervention

study group

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children with c.p. hemiplegia
  • moving and performing daily activities independently
  • no problems in terms of verbal communication
  • no physical and cognitive restrictions.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National institute for Gerontology

Cairo, 62511, Egypt

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • mohammed s Saif, phd

    National institute for Gerontology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

mohammed yo elhamrawy, phd

CONTACT

002 01282805567dr_melhamrawy@yahoo.com

mohammed s saif, phd

CONTACT

002 01223456757

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 21, 2022

First Posted

July 25, 2022

Study Start

January 15, 2022

Primary Completion

April 30, 2023

Study Completion

October 1, 2023

Last Updated

January 25, 2023

Record last verified: 2023-01

Locations

EG(1)