Lower Extremity BurnsNCT05749003
Sensorimotor Training Exercise After Lower Extremity Burns
A study testing sensorimotor training exercise and conventional physical therapy program of exercise. in people with Lower Extremity Burns, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Lower Extremity Burns
- What is being tested?
- sensorimotor training exercise and conventional physical therapy program of exercise.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Cognitive or mentality dysfunctions.
- Psychiatric conditions.
- Fractures.
- Pregnancy.
- Cancer.
- Severe vascular complications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Sensorimotor Training Exercise After Lower Extremity Burns, Prospective Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Lower Extremity Burns
- Being tested
- sensorimotor training exercise, conventional physical therapy program of exercise.
- Keywords
- Sensorimotor training, Stability, Mobility, Balance, Burn
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| sensorimotor training program group | Experimental | participants will receive Sensorimotor training exercise plus conventional physical therapy program of exercise. Receives: Other: sensorimotor training exercise; Other: conventional physical therapy program of exercise. |
| Control group | Other | participants will receive conventional physical therapy program of exercise. Receives: Other: conventional physical therapy program of exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 months
Secondary outcomes (3)
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.
Measured: 2 months
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.
Measured: 2 months
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start1 Feb 2023
- Primary completion30 Dec 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity BurnsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesma Morgan Allam, Cairo University
- Investigators
- Hadaya M Eladl, PhD, Study chair, Assisstant professor of physical therapy for surgery, Faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749003
- Sponsor's protocol ID
- P.T.REC/012/004323
- Status last verified
- Feb 2023
- First submitted
- 18 Feb 2023
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study results
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sensorimotor Training Exercise After Lower Extremity Burns, Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05749003
- Acronym / sponsor ID
- P.T.REC/012/004323
- Conditions
- Lower Extremity Burns
- Keywords
- Sensorimotor training, Stability, Mobility, Balance, Burn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 1 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sensorimotor training program group | Experimental | Other: sensorimotor training exercise, Other: conventional physical therapy program of exercise.participants will receive Sensorimotor training exercise plus conventional physical therapy program of exercise. |
| Control group | Other | Other: conventional physical therapy program of exercise.participants will receive conventional physical therapy program of exercise. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Cognitive or mentality dysfunctions.
- Psychiatric conditions.
- Fractures.
- Pregnancy.
- Cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sensorimotor training exercisePatients 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. | Other | sensorimotor training program group |
| conventional physical therapy program of exercise.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. | Other | Control group, sensorimotor training program group |
Primary outcome
Stability assessment
Time frame: 2 months
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
Time frame: 2 months
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.
3 secondary outcomes
Mobility assessment
Time frame: 2 months
Quality of life (36-Item Short Form Health Survey (SF-36).
Time frame: 2 months
Muscle Torque assessment
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: Yes. Study results
Related trials for Lower Extremity Burns
RecruitingObservational study
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Enrolling by invitation
Clinical Effectiveness of Robot-assisted Gait Training in Patients With Lower Limb Burns Accompanied by Fractures: Pilot Study
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Enrolling by invitationObservational study
Clinical Registry Collecting Real World Evidence on Wound Care Treatments
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Not yet recruitingPhase 3
Efficacy of Carbonlife Amniotic Tissue Product in the Treatment of Chronic Wounds
Chronic Wounds, Venous Leg Ulcers (VLUs)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hadaya M Eladl, PhD study chair
Assisstant professor of physical therapy for surgery, Faculty of physical therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sensorimotor training exercise and conventional physical therapy program of exercise. in people with Lower Extremity Burns, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stability assessment (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2024.