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Sensorimotor Training Exercise After Lower Extremity Burns

Primary Purpose

Lower Extremity Burns

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
sensorimotor training exercise
conventional physical therapy program of exercise.
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lower Extremity Burns focused on measuring Sensorimotor training, Stability, Mobility, Balance, Burn

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: Cognitive or mentality dysfunctions. Psychiatric conditions. Fractures. Pregnancy. Cancer. Severe vascular complications.

Sites / Locations

  • Nesma Morgan AllamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

sensorimotor training program group

Control group

Arm Description

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

participants will receive conventional physical therapy program of exercise.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Mobility assessment
For assessment of mobility, the timed-up and go test was used. The test asks the participant to raise up from the sitting position followed by walking for 3 m, turning around, sitting again on the chair with his back supported, and resting his arms on the armrests. A stopwatch was used to measure the time in seconds for each participant to finish the task. The test was repeated for three trials, and the best or lowest trial time was documented for analysis.
Quality of life (36-Item Short Form Health Survey (SF-36).
HRQoL using the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). The SF-36 is a generic measure of HRQoL that contains 36 items grouped into: physical functioning, physical role functioning, bodily pain, general health perceptions, vitality, social role functioning, emotional role functioning, and mental health. Scores on each subscale range from 0 to 100, with 0 corresponding to the worst health status and 100 to the best health status.
Muscle Torque assessment
The therapist will perform the initial evaluation of knee extensor muscles of the dominant burned limb with Biodex isokinetic dynamometer (Biodex Medical System, Shiley, NY, USA, linked to IBM PC-computer software). After a 5-min warm-up on the treadmill without resistance, the participants will be positioned in an isokinetic dynamometer with hip angle of 100°. The trunk, pelvis and thigh will be stabilized using straps, in accordance with the Test and Rehabilitation System User's Guide of Biodex.

Full Information

First Posted
February 18, 2023
Last Updated
February 18, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05749003
Brief Title
Sensorimotor Training Exercise After Lower Extremity Burns
Official Title
Effect of Sensorimotor Training Exercise After Lower Extremity Burns, Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Burns to the lower limbs can cause pain, scar tissue contracture, impaired sensation, muscle weakness and postural imbalance are all potential complications of lower limb burn injury (LLBI) which negatively influence a person's ability to function normally Sensorimotor training is a special form of proprioceptive and balance exercise that was designed for management of patients with chronic musculoskeletal pain syndromes. It is based on the concept that instead of emphasizing the isolated strength of a group of muscles around a joint, we should realize the importance of the central nervous system in regulating movement in order to reach proper firing patterns for maintaining joint stability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Extremity Burns
Keywords
Sensorimotor training, Stability, Mobility, Balance, Burn

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
sensorimotor training program group
Arm Type
Experimental
Arm Description
participants will receive Sensorimotor training exercise plus conventional physical therapy program of exercise.
Arm Title
Control group
Arm Type
Other
Arm Description
participants will receive conventional physical therapy program of exercise.
Intervention Type
Other
Intervention Name(s)
sensorimotor training exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
conventional physical therapy program of exercise.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stability assessment
Description
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.
Time Frame
2 months
Title
Balance assessment
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Mobility assessment
Description
For assessment of mobility, the timed-up and go test was used. The test asks the participant to raise up from the sitting position followed by walking for 3 m, turning around, sitting again on the chair with his back supported, and resting his arms on the armrests. A stopwatch was used to measure the time in seconds for each participant to finish the task. The test was repeated for three trials, and the best or lowest trial time was documented for analysis.
Time Frame
2 months
Title
Quality of life (36-Item Short Form Health Survey (SF-36).
Description
HRQoL using the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36). The SF-36 is a generic measure of HRQoL that contains 36 items grouped into: physical functioning, physical role functioning, bodily pain, general health perceptions, vitality, social role functioning, emotional role functioning, and mental health. Scores on each subscale range from 0 to 100, with 0 corresponding to the worst health status and 100 to the best health status.
Time Frame
2 months
Title
Muscle Torque assessment
Description
The therapist will perform the initial evaluation of knee extensor muscles of the dominant burned limb with Biodex isokinetic dynamometer (Biodex Medical System, Shiley, NY, USA, linked to IBM PC-computer software). After a 5-min warm-up on the treadmill without resistance, the participants will be positioned in an isokinetic dynamometer with hip angle of 100°. The trunk, pelvis and thigh will be stabilized using straps, in accordance with the Test and Rehabilitation System User's Guide of Biodex.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Cognitive or mentality dysfunctions. Psychiatric conditions. Fractures. Pregnancy. Cancer. Severe vascular complications.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nesma M Allam, PhD
Phone
+201281968332
Email
dr.nesma2011@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadaya M Eladl, PhD
Organizational Affiliation
Assisstant professor of physical therapy for surgery, Faculty of physical therapy
Official's Role
Study Chair
Facility Information:
Facility Name
Nesma Morgan Allam
City
Tanta
ZIP/Postal Code
12111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nesma M Allam, PhD
Phone
+201281968332
Email
dr.nesma2011@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study results
IPD Sharing Time Frame
6 months after publication
IPD Sharing Access Criteria
Study protocol

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Sensorimotor Training Exercise After Lower Extremity Burns

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