NCT05749003

Brief Summary

Burn injury affects dermal tissue which contains sensory neurones that contribute to the conscious and automatic feedback systems which in turn, control balance and coordination. Impediments arising from lower limb burn injuries are similar to those observed in other populations suffering lower limb disease or pathology and further, these complications cause balance dysfunction. Balance and mobility are complex bodily functions integral to discharge disposition, social function and quality of life. Therefore, to guide recovery accurately and facilitate rehabilitation after LLBI, multi-factorial assessment is required.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2024

Completed
Last Updated

September 20, 2024

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

February 18, 2023

Last Update Submit

September 19, 2024

Conditions

Lower Extremity Burns

Keywords

Sensorimotor trainingStabilityMobilityBalanceBurn

Outcome Measures

Primary Outcomes (2)

  • Stability assessment

    Biodex balance scale (Biodex medical systems Inc, Shirley, New York, USA), will be used for balance assessment. Anteroposterior stability index, mediolateral stability index, and overall stability index will be used to assess fluctuations around the zero point representing standard deviations rather than around a group mean.

    2 months

  • Balance assessment

    The Berg balance scale includes 14 items with scores from 0 to 4. A score of 0 represents the inability to do the task, while a score of 4 represents the ability to do the task completely, according to the assigned criteria, with 56 indicates the total score.

    2 months

Secondary Outcomes (3)

  • Mobility assessment

    2 months

  • Quality of life (36-Item Short Form Health Survey (SF-36).

    2 months

  • Muscle Torque assessment

    2 months

Study Arms (2)

sensorimotor training program group

EXPERIMENTAL

participants will receive Sensorimotor training exercise plus conventional physical therapy program of exercise.

Other: sensorimotor training exerciseOther: conventional physical therapy program of exercise.

Control group

OTHER

participants will receive conventional physical therapy program of exercise.

Other: conventional physical therapy program of exercise.

Interventions

sensorimotor training exerciseOTHER

Patients will be trained through three stages: static, dynamic and functional. Each exercise will be repeated 3-5 times during a session and with enough periods of rest between each set of exercises. The exercise graduated from easy to more difficult and the patient was not progressed to a more difficult stage until performing the easier one.

sensorimotor training program group
conventional physical therapy program of exercise.OTHER

stretching exercise for 30 minutes, then strengthening exercise and usual burn care for the lower extremity. Exercises will be applied for 3 times a week for 8 consecutive weeks.

Control groupsensorimotor training program group

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of thermal burn injuries at the lower extremities.
  • Total body surface area burned approximately from 40 to 50%.
  • Patients age: 20 to 50 years.

You may not qualify if:

  • Cognitive or mentality dysfunctions.
  • Psychiatric conditions.
  • Fractures.
  • Pregnancy.
  • Cancer.
  • Severe vascular complications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nesma Morgan Allam

Tanta, 12111, Egypt

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Hadaya M Eladl, PhD

    Assisstant professor of physical therapy for surgery, Faculty of physical therapy

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of physical therapy for surgery, Faculty of physical therapy

Study Record Dates

First Submitted

February 18, 2023

First Posted

March 1, 2023

Study Start

February 1, 2023

Primary Completion

December 30, 2023

Study Completion

January 30, 2024

Last Updated

September 20, 2024

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

Study results

Shared Documents
STUDY PROTOCOL
Time Frame
6 months after publication
Access Criteria
Study protocol

Locations

EG(1)