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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Egypt
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Sensory motor training
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.
Other: Traditional physical therapy
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.
Other: Traditional physical therapy
traditional physical therapy program in form of stretching exercises, strengthening exercises, scar management, and gait training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shaimaa Mohamed Ahmed Elsayeh

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 9, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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