NCT06632223

Brief 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 9, 2024

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

September 28, 2024

Last Update Submit

October 7, 2024

Conditions

Keywords

Sensory motor trainingFoot weight distributionPostural stabilityFoot burn

Outcome Measures

Primary Outcomes (2)

  • 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.

    "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.

    "At baseline and after 8 weeks of intervention"

Secondary Outcomes (1)

  • The Brief Burn Specific Health Scale-Brief

    "At baseline and after 8 weeks of intervention"

Study Arms (2)

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.

Other: Sensory motor trainingOther: 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.

Other: Traditional physical therapy

Interventions

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.

Sensory-motor training group

traditional physical therapy program in form of stretching exercises, strengthening exercises, scar management, and gait training

Sensory-motor training groupTraditional physical therapy group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients will suffer from foot \"planter surface\" second degree thermal burn (Partial thickness).
  • Patients will begin the training program after complete wound healing.
  • Patients will be given their informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo University, Egypt.

Cairo, Giza Governorate, 12611, Egypt

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Physical Therapy

Study Record Dates

First Submitted

September 28, 2024

First Posted

October 9, 2024

Study Start

July 1, 2024

Primary Completion

November 1, 2024

Study Completion

December 1, 2024

Last Updated

October 9, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations