Thermal BurnNCT04500314
Efficacy of Whole-body Vibration on Balance Control, Postural Stability and Mobility After Thermal Burn Injuries.
A study testing whole body vibration device and routine physical therapy treatment in people with Thermal Burn, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to investigate the effect of whole-body vibration device on Balance control, postural Stability and mobility after thermal burn injuries. Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Thermal Burn
- What is being tested?
- whole body vibration device and routine physical therapy treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Aug 2020to 28 Dec 2020
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ranged between 20 and 45 years,
- Deep 2nd degree of thermal burn of lower limb and trunk with (35-40%) surface area of burn as measured by "rule of nine" method, with complete wound healing or after 6 weeks from the injury.
- Body mass index of between 17 and 35, with no history of neurological disorders or injuries to the lower extremities.
Who cannot join
- Patients with open burn wound,
- Patients diagnosed with acute rheumatoid arthritis,
- Joint replacement within the past year,
- History of traumatic spine within the past six months,
- Prosthesis,
- Recent fracture or bone disease.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cairo University, Faculty of physical therapy.
Cairo, Giza Governorate, 12322
About this study
Official title: Efficacy of Whole-body Vibration on Balance Control, Postural Stability and Mobility After Thermal Burn Injuries. Prospective Randomized Controlled Trial.
This study will be conducted to investigate the effect of whole-body vibration device on Balance control, postural Stability and mobility after thermal burn injuries.
Read the detailed description
40 patients with deep second-degree burn involving the lower limbs and trunk (TBSA: 35-40%), will be randomly assigned either into the experimental group, received whole body vibration (WBV) plus the routine physical therapy program or the control group, received the same routine physical therapy program. All treatment interventions will be applied at a frequency of three sessions per week for 8 weeks. Anteroposterior stability (APS), Medial lateral stability (MLS), Time up and go test (TUG) test, and Berg balance scale will be the outcome measures of the study.
- Conditions
- Thermal Burn
- Being tested
- whole body vibration device, routine physical therapy treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole body vibration deviceDevice
20 patients will receive vibration training on vibration platform (Power Plate International, Irvine, California, USA) at a frequency of 25-30 Hz and amplitude of 3-5mm, plus traditional physical therapy program 3 sessions per week for total period of 8 weeks. The total duration of the WBV training stimulus will 10 min in first week and progress gradually to 25 min in the 8th week with regular increase by 5 minutes after each 2 successive weeks
routine physical therapy treatmentOther
The program consists of 60 minutes supervised and individualized stretching exercise to all involved muscles followed by strengthening for affected muscles, mobilizing exercise for the joints involved to increase the joint range of motion, in addition to scar management techniques including pressure garments, inserts, and physical agent modalities , to avoid scar or contracture formation
| Study group | Role | What they receive |
|---|---|---|
| Whole body vibration plus routine physical therapy | Experimental | Not described Receives: Device: whole body vibration device; Other: routine physical therapy treatment |
| Routine physical therapy | Active comparator | Not described Receives: Other: routine physical therapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural stability
The antero-posterior stability index (APSI) was measured for all cases before and after eight weeks of treatment. This index will be standard deviations assessing fluctuations around the zero point (horizontal) rather than around a group mean. The APSI assessed the fluctuations from the horizontal along the AP on the BSS
Measured: 8 weeks of treatment
Secondary outcomes (1)
Time up and go test
The TUG test used to measure mobility. Participants were asked to raise up from sitting in a chair to a standing position and to walk a distance of 3 m, turn around, walk back to the chair, and sit down again with their backs flush to the back of the chair and with arms resting on the arm rests. The time for participants to complete the task was measured in seconds with a stopwatch. The best, or lowest time from 3 trials, was used in the analysis
Measured: 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start5 Aug 2020
- Primary completion25 Dec 2020
- Study completion28 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thermal BurnStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadaya Mosaad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500314
- Sponsor's protocol ID
- 182020
- Status last verified
- Mar 2021
- First submitted
- 26 Jul 2020
- Last updated
- 17 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: after 6 month from the date of publication
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Whole-body Vibration on Balance Control, Postural Stability and Mobility After Thermal Burn Injuries. Prospective Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04500314
- Acronym / sponsor ID
- 182020
- Conditions
- Thermal Burn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 25 Dec 2020 (actual)
- Study completion
- 28 Dec 2020 (actual)
- First posted
- 5 Aug 2020 (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.
This study will be conducted to investigate the effect of whole-body vibration device on Balance control, postural Stability and mobility after thermal burn injuries.
Detailed description
40 patients with deep second-degree burn involving the lower limbs and trunk (TBSA: 35-40%), will be randomly assigned either into the experimental group, received whole body vibration (WBV) plus the routine physical therapy program or the control group, received the same routine physical therapy program. All treatment interventions will be applied at a frequency of three sessions per week for 8 weeks. Anteroposterior stability (APS), Medial lateral stability (MLS), Time up and go test (TUG) test, and Berg balance scale will be the outcome measures of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole body vibration plus routine physical therapy | Experimental | Device: whole body vibration device, Other: routine physical therapy treatment |
| Routine physical therapy | Active comparator | Other: routine physical therapy treatment |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age ranged between 20 and 45 years,
- Deep 2nd degree of thermal burn of lower limb and trunk with (35-40%) surface area of burn as measured by "rule of nine" method, with complete wound healing or after 6 weeks from the injury.
- Body mass index of between 17 and 35, with no history of neurological disorders or injuries to the lower extremities.
Key exclusion criteria (6 listed)
- Patients with open burn wound,
- Patients diagnosed with acute rheumatoid arthritis,
- Joint replacement within the past year,
- History of traumatic spine within the past six months,
- Prosthesis,
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 |
|---|---|---|
| whole body vibration device20 patients will receive vibration training on vibration platform (Power Plate International, Irvine, California, USA) at a frequency of 25-30 Hz and amplitude of 3-5mm, plus traditional physical therapy program 3 sessions per week for total period of 8 weeks. The total duration of the WBV training stimulus will 10 min in first week and progress gradually to 25 min in the 8th week with regular increase by 5 minutes after each 2 successive weeks | Device | Whole body vibration plus routine physical therapy |
| routine physical therapy treatmentThe program consists of 60 minutes supervised and individualized stretching exercise to all involved muscles followed by strengthening for affected muscles, mobilizing exercise for the joints involved to increase the joint range of motion, in addition to scar management techniques including pressure garments, inserts, and physical agent modalities , to avoid scar or contracture formation | Other | Routine physical therapy, Whole body vibration plus routine physical therapy |
Primary outcome
Postural stability
Time frame: 8 weeks of treatment
The antero-posterior stability index (APSI) was measured for all cases before and after eight weeks of treatment. This index will be standard deviations assessing fluctuations around the zero point (horizontal) rather than around a group mean. The APSI assessed the fluctuations from the horizontal along the AP on the BSS
1 secondary outcome
Time up and go test
Time frame: 8 weeks of treatment
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 17 Mar 2021.
- Individual participant dataSharing planned: Yes. after 6 month from the date of publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole body vibration device and routine physical therapy treatment in people with Thermal Burn, 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 17 Mar 2021. 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?
Postural stability (time frame: 8 weeks of treatment). 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 17 Mar 2021.