BurnedNCT06036082
Isokinetic Training Versus Treadmill Training on Muscle Strength and Gait in Children With Lower Limb Burns
A study testing Conventional physical therapy in people with Burned, run by South Valley University at 1 site in Egypt.
Trial summary
Burn wounds are one of the most complexes and dramatic of all injuries, it produces a direct local tissue destruction and damage. In addition, burn wounds may continue to destroy tissue and muscles, exercise therapy stimulates the early expression of angiogenesis-related growth factors so it results in new vessel… Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Burned
- What is being tested?
- Conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2023to 20 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 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged between 8 to 16 year
- Complaining from 2nd degree lower limb burns (≥30 % of their TBSA).
- Capable of standing and walking independently.
- Clinically and medically stable.
- Sufficient cognition demonstrating understanding the requirements of the study.
- No history of lower extremity surgery.
Who cannot join
- Visual and/or auditory defects.
- Significant shortening and/or deformity of lower extremities.
- Other neurological problems that affect balance or mentality (e.g. epilepsy).
- Advanced radiographic changes include (bone destruction, bony ankylosis, knee joint sublaxation and epiphysial fracture).
- Congenital or acquired skeletal deformities in the lower limbs.
- Cardiopulmonary dysfunction.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ragaee Saeed Mahmoud
Faisal, Giza Governorate, 00202
Ragaee Mahmoud, 00201223611112, ragaeesaeedpt10@gmail.com
Reham Mahmoud, 00201015447798, rsm_211pt@yahoo.com
About this study
Official title: Improvement by Isokinetic and Treadmill Training on Muscle Strength and Gait in Burned Children
Burn wounds are one of the most complexes and dramatic of all injuries, it produces a direct local tissue destruction and damage. In addition, burn wounds may continue to destroy tissue and muscles, exercise therapy stimulates the early expression of angiogenesis-related growth factors so it results in new vessel in-growth that improves blood supply, increases cell proliferation, accelerates tissue regeneration and healing and regain muscle strength
Read the detailed description
To evaluate the efficacy of isokinetic training against treadmill training in improving muscle strength and gait in children having lower limb burns. Methods: Sixty children from both genders (boys and girls) who were complaining from 2nd degree lower limb burns with ≥30 percent of their total body surface area (TBSA) participated in this study, their ages ranged from 8 to 16 years and they were randomized into three groups of same number (A, B and C). Groups (A) received conventional physical therapy program, group (B) received the same conventional physical therapy program of group (A) with trained to use the isokinetic device while group (C) received the same conventional physical therapy program of group (A and B) and used treadmill training. The children participated in this study were assessed by Hand-held dynamometer (HHD) and Balance Master System (BMS). They were evaluated before and after the treatment program three sessions per week for 12 consecutive weeks.
- Conditions
- Burned
- Being tested
- Conventional physical therapy
- Keywords
- Burn; Children; Isokinetic Training; Treadmill Training
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physical therapyOther
Also called physical therapy program
- Standing with feet together .
- Step standing .
- High step standing and trying to keep balanced.
- Single leg stance "unilateral standing" with assistance.
- Standing on a declined surface by using wedge.
- Standing with manual locking of the knees.
- Changing position.
- Gait training.
- Static and dynamic muscle contraction.
| Study group | Role | What they receive |
|---|---|---|
| Conventional physical therapy group | Experimental | It consisted of 20 children received conventional physical therapy program Receives: Other: Conventional physical therapy |
| isokinetic training group | Experimental | It consisted of 20 children received conventional physical therapy program and isokinetic training Receives: Other: Conventional physical therapy |
| Treadmill training group | Experimental | It consisted of 20 children received conventional physical therapy program and treadmill training Receives: Other: Conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance Master System
It is the most significant test to measure balance and has valid values of functional balance performance
Measured: before intervention and after 12 weeks of intervention
Secondary outcomes (1)
Hand-held dynamometer
It is a portable device (Nicholas Manual Muscle Tester, Model 01160; Lafayette Instrument, Lafayette, IN), characterized as low-cost and convenient method
Measured: before intervention and after 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start15 Oct 2023 (estimated)
- Primary completion15 Jan 2024 (estimated)
- Study completion20 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnedStudies of the same condition, open and under way.
- 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
- Model description
- randomized control study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ragaee Saeed Mahmoud, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036082
- Sponsor's protocol ID
- REC/2111/MTI.PT/2204062
- Status last verified
- Oct 2023
- First submitted
- 2 Sep 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: assessed before and after treatment
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement by Isokinetic and Treadmill Training on Muscle Strength and Gait in Burned Children
- ClinicalTrials.gov ID
- NCT06036082
- Acronym / sponsor ID
- REC/2111/MTI.PT/2204062
- Conditions
- Burned
- Keywords
- Burn; Children; Isokinetic Training; Treadmill Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 15 Oct 2023 (estimated)
- Primary completion
- 15 Jan 2024 (estimated)
- Study completion
- 20 Jan 2024 (estimated)
- First posted
- 13 Sep 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 wounds are one of the most complexes and dramatic of all injuries, it produces a direct local tissue destruction and damage. In addition, burn wounds may continue to destroy tissue and muscles, exercise therapy stimulates the early expression of angiogenesis-related growth factors so it results in new vessel in-growth that improves blood supply, increases cell proliferation, accelerates tissue regeneration and healing and regain muscle strength
Detailed description
To evaluate the efficacy of isokinetic training against treadmill training in improving muscle strength and gait in children having lower limb burns. Methods: Sixty children from both genders (boys and girls) who were complaining from 2nd degree lower limb burns with ≥30 percent of their total body surface area (TBSA) participated in this study, their ages ranged from 8 to 16 years and they were randomized into three groups of same number (A, B and C). Groups (A) received conventional physical therapy program, group (B) received the same conventional physical therapy program of group (A) with trained to use the isokinetic device while group (C) received the same conventional physical therapy program of group (A and B) and used treadmill training. The children participated in this study were assessed by Hand-held dynamometer (HHD) and Balance Master System (BMS). They were evaluated before and after the treatment program three sessions per week for 12 consecutive weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- randomized control study
| Arm | Type | Receives |
|---|---|---|
| Conventional physical therapy group | Experimental | Other: Conventional physical therapyIt consisted of 20 children received conventional physical therapy program |
| isokinetic training group | Experimental | Other: Conventional physical therapyIt consisted of 20 children received conventional physical therapy program and isokinetic training |
| Treadmill training group | Experimental | Other: Conventional physical therapyIt consisted of 20 children received conventional physical therapy program and treadmill training |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged between 8 to 16 year
- Complaining from 2nd degree lower limb burns (≥30 % of their TBSA).
- Capable of standing and walking independently.
- Clinically and medically stable.
- Sufficient cognition demonstrating understanding the requirements of the study.
Key exclusion criteria (6 listed)
- Visual and/or auditory defects.
- Significant shortening and/or deformity of lower extremities.
- Other neurological problems that affect balance or mentality (e.g. epilepsy).
- Advanced radiographic changes include (bone destruction, bony ankylosis, knee joint sublaxation and epiphysial fracture).
- Congenital or acquired skeletal deformities in the lower limbs.
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 |
|---|---|---|
| Conventional physical therapyAlso: physical therapy program* Standing with feet together . * Step standing . * High step standing and trying to keep balanced. * Single leg stance "unilateral standing" with assistance. * Standing on a declined surface by using wedge. * Standing with manual locking of the knees. * Changing position. * Gait training. * Static and dynamic muscle contraction. | Other | Conventional physical therapy group, Treadmill training group, isokinetic training group |
Primary outcome
Balance Master System
Time frame: before intervention and after 12 weeks of intervention
It is the most significant test to measure balance and has valid values of functional balance performance
1 secondary outcome
Hand-held dynamometer
Time frame: before intervention and after 12 weeks of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Individual participant dataSharing planned: Yes. assessed before and after treatment
Related trials for Burned
RecruitingObservational study
Monitoring the Clinical and Immunological Effects of Microbiome Changes Following Severe Burn Injury
Severely Burned Patients, Gut Microbiota Diversity and Composition
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional physical therapy in people with Burned, run by South Valley 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 6 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: status not confirmed, as of the sponsor's last update on 13 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance Master System (time frame: before intervention and after 12 weeks of intervention). 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 13 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.