BurnNCT06632223
Sensory Motor Training on Foot Weight Distribution in Patients With Foot Burn
A study testing Sensory motor training and Traditional physical therapy in people with Burn and Postural Stability, run by Shaimaa Mohamed Ahmed Elsayeh at 1 site in Egypt.
Trial summary
The purpose of the current study is to investigate the effect sensory motor training on foot weight distribution and postural stability in patients with foot burn. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Burn, Postural Stability
- What is being tested?
- Sensory motor training and Traditional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to Dec 2024
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients will suffer from foot \"planter surface\" second degree thermal burn (Partial thickness).
- Patients who have undergone skin grafting and those who have not undergone skin grafting are both eligible for inclusion in the study.
- Patients will begin the training program after complete wound healing.
- Patients will be given their informed consent.
Who cannot join
- Patients who had an open wound at or near treatment site.
- Patients who had chemical or electrical burn.
- Patients with specific conditions such as musculoskeletal impairments impacting independent walking (e.g., strokes, severe arthritis).
- Uncontrolled cardiovascular or pulmonary diseases.
- Patients with neurological, psychiatric illness, severe behavior or cognitive disorders.
- Metabolic or vascular disease with a neurological component such as diabetes.
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- Patients with hearing problems, individuals with otitis media, and patients experiencing nystagmus and visual problems.
- Malignant conditions.
- Uncooperative patients.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy, Cairo University, Egypt.
Cairo, Giza Governorate, 12611
About this study
Official title: The Effect of Sensory Motor Training on Foot Weight Distribution and Postural Stability in Patients With Foot Burn
The purpose of the current study is to investigate the effect sensory motor training on foot weight distribution and postural stability in patients with foot burn.
Read the detailed description
Pain, contractures, scars, altered sensations, muscle weakness, and postural balance impairment are potential complications of foot burn that negatively influence a person\'s ability to function normally and correlate with gait abnormalities like reduced step height and length, along with slower gait speed. These gait disturbances pose significant challenges for burn patients, affecting their mobility and overall quality of life. So, this study aims to understanding how sensory motor training can improve balance, gait, and overall functional mobility is essential for guiding the development of evidence-based rehabilitation protocols tailored to the unique needs of this population.
- Conditions
- Burn, Postural Stability
- Being tested
- Sensory motor training, Traditional physical therapy
- Keywords
- Sensory motor training, Foot weight distribution, Postural stability, Foot burn
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory motor trainingOther
Each session will be composed of 10 minutes of warm-up, followed by 50-60 minutes of sensory motor exercises, followed by 5-10 minutes of cool down.
Traditional physical therapyOther
traditional physical therapy program in form of stretching exercises, strengthening exercises, scar management, and gait training
| Study group | Role | What they receive |
|---|---|---|
| Sensory-motor training group | Experimental | This group will include 35 patients with foot burns. Patients will receive sensorimotor training exercise in addition to a traditional physical therapy program in the form of stretching exercises, strengthening exercises and scar management. Exercises will be applied for 3 times a week for 8 consecutive weeks. Receives: Other: Sensory motor training; Other: Traditional physical therapy |
| Traditional physical therapy group | Active comparator | This group will include 35 patients with foot burns. Patients will receive the traditional physical therapy program only in the form of stretching exercises, strengthening exercises and scar management. Exercises will be applied for 3 times a week for 8 consecutive weeks. Receives: Other: Traditional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Pedoscan system
It will be used to assess the foot weight distribution. Under the guidance of the evaluator, the subjects will stand with bare feet upon a part marked on the platform with eyes closed.
Measured: "At baseline and after 8 weeks of intervention"
The biodex balance system
It will be used to assess the postural stability during assessment; participants will stand comfortably on the platform barefoot, with arms at their sides, for 30 seconds.
Measured: "At baseline and after 8 weeks of intervention"
Secondary outcomes (1)
The Brief Burn Specific Health Scale-Brief
Its Arabic version will be used to assess the quality of life. The Burn Specific Health Scale-Brief consists of 40 items covering nine domains related to health-related quality of life (HRQL): simple abilities, heat sensitivity, hand function, treatment regimens, work, body image, affect, interpersonal relationships, and sexuality. Responses to each item are scored on a five-point scale ranging from 0 (extremely) to 4 (not at all). Mean scores per domain are assessed, and high scores indicate a good perceived health status
Measured: "At baseline and after 8 weeks of intervention"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start1 Jul 2024
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaimaa Mohamed Ahmed Elsayeh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shaimaa Mohamed Ahmed Elsayeh, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632223
- Sponsor's protocol ID
- P.T.REC/012/005257
- Status last verified
- Oct 2024
- First submitted
- 28 Sep 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sensory Motor Training on Foot Weight Distribution and Postural Stability in Patients With Foot Burn
- ClinicalTrials.gov ID
- NCT06632223
- Acronym / sponsor ID
- P.T.REC/012/005257
- Conditions
- Burn, Postural Stability
- Keywords
- Sensory motor training, Foot weight distribution, Postural stability, Foot burn
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Shaimaa Mohamed Ahmed ElsayehUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 9 Oct 2024 (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.
The purpose of the current study is to investigate the effect sensory motor training on foot weight distribution and postural stability in patients with foot burn.
Detailed description
Pain, contractures, scars, altered sensations, muscle weakness, and postural balance impairment are potential complications of foot burn that negatively influence a person\'s ability to function normally and correlate with gait abnormalities like reduced step height and length, along with slower gait speed. These gait disturbances pose significant challenges for burn patients, affecting their mobility and overall quality of life. So, this study aims to understanding how sensory motor training can improve balance, gait, and overall functional mobility is essential for guiding the development of evidence-based rehabilitation protocols tailored to the unique needs of this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensory-motor training group | Experimental | Other: Sensory motor training, Other: Traditional physical therapyThis group will include 35 patients with foot burns. Patients will receive sensorimotor training exercise in addition to a traditional physical therapy program in the form of stretching exercises, strengthening exercises and scar management. Exercises will be applied for 3 times a week for 8 consecutive weeks. |
| Traditional physical therapy group | Active comparator | Other: Traditional physical therapyThis group will include 35 patients with foot burns. Patients will receive the traditional physical therapy program only in the form of stretching exercises, strengthening exercises and scar management. Exercises will be applied for 3 times a week for 8 consecutive weeks. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients will suffer from foot \"planter surface\" second degree thermal burn (Partial thickness).
- Patients who have undergone skin grafting and those who have not undergone skin grafting are both eligible for inclusion in the study.
- Patients will begin the training program after complete wound healing.
- Patients will be given their informed consent.
Key exclusion criteria (9 listed)
- Patients who had an open wound at or near treatment site.
- Patients who had chemical or electrical burn.
- Patients with specific conditions such as musculoskeletal impairments impacting independent walking (e.g., strokes, severe arthritis).
- Uncontrolled cardiovascular or pulmonary diseases.
- Patients with neurological, psychiatric illness, severe behavior or cognitive disorders.
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 |
|---|---|---|
| Sensory motor trainingEach session will be composed of 10 minutes of warm-up, followed by 50-60 minutes of sensory motor exercises, followed by 5-10 minutes of cool down. | Other | Sensory-motor training group |
| Traditional physical therapytraditional physical therapy program in form of stretching exercises, strengthening exercises, scar management, and gait training | Other | Sensory-motor training group, Traditional physical therapy group |
Primary outcome
The Pedoscan system
Time frame: "At baseline and after 8 weeks of intervention"
It will be used to assess the foot weight distribution. Under the guidance of the evaluator, the subjects will stand with bare feet upon a part marked on the platform with eyes closed.
The biodex balance system
Time frame: "At baseline and after 8 weeks of intervention"
It will be used to assess the postural stability during assessment; participants will stand comfortably on the platform barefoot, with arms at their sides, for 30 seconds.
1 secondary outcome
The Brief Burn Specific Health Scale-Brief
Time frame: "At baseline and after 8 weeks of intervention"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory motor training and Traditional physical therapy in people with Burn and Postural Stability, run by Shaimaa Mohamed Ahmed Elsayeh 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 9 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 9 Oct 2024. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Pedoscan system (time frame: "At baseline and after 8 weeks of intervention"). 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 9 Oct 2024.