- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06632223
Sensory Motor Training on Foot Weight Distribution in Patients With Foot Burn
October 7, 2024 updated by: Shaimaa Mohamed Ahmed Elsayeh
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Giza
-
Cairo, Giza, Egypt, 12611
- Faculty of Physical Therapy, Cairo University, Egypt.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Patients with hearing problems, individuals with otitis media, and patients experiencing nystagmus and visual problems.
- Malignant conditions.
- Uncooperative patients.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sensory-motor training group
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.
|
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 therapy program in form of stretching exercises, strengthening exercises, scar management, and gait training
|
|
Active Comparator: Traditional physical therapy group
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.
|
traditional physical therapy program in form of stretching exercises, strengthening exercises, scar management, and gait training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
"At baseline and after 8 weeks of intervention"
|
|
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.
|
"At baseline and after 8 weeks of intervention"
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Brief Burn Specific Health Scale-Brief
Time Frame: "At baseline and after 8 weeks of intervention"
|
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
|
"At baseline and after 8 weeks of intervention"
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2024
Primary Completion (Estimated)
November 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
September 28, 2024
First Submitted That Met QC Criteria
October 7, 2024
First Posted (Estimated)
October 9, 2024
Study Record Updates
Last Update Posted (Estimated)
October 9, 2024
Last Update Submitted That Met QC Criteria
October 7, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005257
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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