StrokeNCT05473390
Effect of FES of Back Muscles on Spinal Posture and Gait in Hemiplegia
A study testing functional electrical stimulation and kinesotaping in people with Stroke, run by Beni-Suef University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 1 year to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- functional electrical stimulation and kinesotaping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2022to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 20 children with c.p. hemiplegia
- moving and performing daily activities independently
- no problems in terms of verbal communication
- no physical and cognitive restrictions.
Who cannot join
- Having cognitive impairment as tested by the Mini-Mental State Examination (with scores < 24)
- Uncontrolled hypertension (systolic blood pressure > 160 mmHg)
- Joint replacement
- Incontinence
Trial locations and contacts
1 site in 1 country.
mohammed s saif, phd contact
Egypt1 site, 1 recruiting
- Recruiting
National institute for Gerontology
Cairo, 62511
Mohamed s Saif, phd, 00201223456757
About this study
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
Read the detailed description
To evaluate whether the application of FES of the back muscles in hemiplegic affect spinal posture and/or gait
- Conditions
- Stroke
- Being tested
- functional electrical stimulation, kinesotaping
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional electrical stimulationOther
functional electrical stimulation on back muscles
kinesotapingOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| study group | Active comparator | 20 patient with hemiplegia Receives: Other: functional electrical stimulation; Other: kinesotaping |
| control group | Active comparator | 20 patient with hemiplegia Receives: Other: functional electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
spinal posture
3 D assessment of spinal posture using Microsoft kinect
Measured: "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)
Measured: "up to 8 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start15 Jan 2022
- Primary completion30 Apr 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Youssef Elhamrawy, Beni-Suef University
- Investigators
- mohammed s Saif, phd, Principal investigator, National institute for Gerontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473390
- Sponsor's protocol ID
- on posture & Balance
- Status last verified
- Jan 2023
- First submitted
- 21 Jul 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of FES of Back Muscles on Spinal Posture and Gait in Hemiplegia
- ClinicalTrials.gov ID
- NCT05473390
- Acronym / sponsor ID
- on posture & Balance
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Active comparator | Other: functional electrical stimulation, Other: kinesotaping20 patient with hemiplegia |
| control group | Active comparator | Other: functional electrical stimulation20 patient with hemiplegia |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 20 children with c.p. hemiplegia
- moving and performing daily activities independently
- no problems in terms of verbal communication
- no physical and cognitive restrictions.
Key exclusion criteria (4 listed)
- Having cognitive impairment as tested by the Mini-Mental State Examination (with scores < 24)
- Uncontrolled hypertension (systolic blood pressure > 160 mmHg)
- Joint replacement
- Incontinence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional electrical stimulationfunctional electrical stimulation on back muscles | Other | control group, study group |
| kinesotapingno intervention | Other | study group |
Primary outcome
spinal posture
Time frame: "up to 8 weeks"
3 D assessment of spinal posture using Microsoft kinect
Balance assessment
Time frame: "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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mohammed s saif, phd contact
mohammed s Saif, phd principal investigator
National institute for Gerontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing functional electrical stimulation and kinesotaping in people with Stroke, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohammed yo elhamrawy, phd (002 01282805567, dr_melhamrawy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spinal posture (time frame: "up to 8 weeks"). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.