Burn InjuryNCT04587102
Whole Body Vibration Training for Diabetic Patients With Burn Injury
A study testing whole body viberation and Traditional program(balance exercises and resisted exercises) in people with Burn Injury, run by Cairo University at 3 sites in 2 countries.
Trial summary
Burn injury as well as diabetes mellitus (DM) induce physical functional and psychological impairments. Lower limb burn involving Foot are still a challenging heath condition because of its important sensory role. Balance is disturbed either in patients with lower limb burn injury or diabetic patients. Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Burn Injury
- What is being tested?
- whole body viberation and Traditional program(balance exercises and resisted exercises)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 10 Jan 2019to 20 Nov 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 40 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- chronic lower limb burns injury for more than 6 months
- Total body surface area (TBSA) burnt ≤ 30%.;
Who cannot join
- cognitive or mentality dysfunctions,
- psychiatric conditions,
- fractures,
- pregnancy,
- cancer,
- severe vascular complications,
- inability to walk
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Egypt2 sites
Zizi Mohammed Ibrahim Ali
Giza, Nnjkjk, 2136
Burn Unit at Om El Masrien Hospital
Giza, 2136
About this study
Official title: Whole Body Vibration Training for Diabetic Patients With Burn Injury: RCT
Burn injury as well as diabetes mellitus (DM) induce physical functional and psychological impairments. Lower limb burn involving Foot are still a challenging heath condition because of its important sensory role. Balance is disturbed either in patients with lower limb burn injury or diabetic patients. This study aime to compare between the effects whole body vibrational training and Yoga exercises on postural balance, and Activities-specific Balance Confidence in in type II diabetic Patients with foot burn
Read the detailed description
Thirty eight diabetic patients (17 male, 21female) with foot burn injury, with their age ranged from 40 to 55 years. They will randomly assigned into two equal groups. Group (A) will receive low vibrational training in the form of whole body vibration for 8 weeks (n=19), while group (B) the control group for 8 weeks (n=19) in addition both groups will receive their routine medical care and physical therapy rehabilitation including balancing exercises. Dynamic balance will be evaluated through Biodex balance system (BBS);and balance confidence will be measured by the Activities-specific Balance Confidence Scale (ABC) before the starting and after the end of treatment for all patients in both groups
- Conditions
- Burn Injury
- Being tested
- whole body viberation, Traditional program(balance exercises and resisted exercises)
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole body viberationOther
Also called WBV
vibration training in the form of whole body vibration for 20-30 minutes per session, 3 sessions per week for 8 weeks. The vibration training was performed on a whole body vibration platform
Traditional program(balance exercises and resisted exercises)Other
balance exercises and resisted exercises
| Study group | Role | What they receive |
|---|---|---|
| whole body viberation :group A | Active comparator | will receive low vibrational training in the form of whole body vibration for 8 weeks Receives: Other: whole body viberation; Other: Traditional program(balance exercises and resisted exercises) |
| control group (B) | Active comparator | control Receives: Other: Traditional program(balance exercises and resisted exercises) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic balance assessment
Biodex Balance System was used to measure the dynamic balance of each patient in both groups (A and B) before and after 8 weeks of treatment.
The system has a movable balance platform that permits about 20◦ tilt in 360◦ range, and is interfaced with computer software for objective balance assessment. It measures the ability of the patient to control the platform's tilting angle, which is quantified as a variation from the center, as well as the deflection degree over time at different stability levels
Measured: Change from Baseline at balance scores at 8 weeks
Secondary outcomes (1)
The Activities-specific Balance
A short,six-question version of the Activities-specific Balance scale, the Activities-specific Balance scale. Individuals report their balance confidence in six tasks: standing on tiptoes and reaching for something overhead, standing on a chair to reach for something, being bumped into by people while walking through a mall, stepping off an escalator holding onto the railing, stepping off an escalator without holding onto the railing, and walking on an icy sidewalk ABC scores range between 0% and 100%, with higher scores indicating better balance confidence
Measured: Change from Baseline at Activities-specific Balance scores at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start10 Jan 2019
- Primary completion12 Sep 2020
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn InjuryStudies 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
- Model description
- vibration Group (A) will receive low vibrational training in the form of whole body vibration for 8 weeks , while group B is the control, both groups will receive their routine medical care and physical therapy rehabilitation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZIZI MOHAMMED IBRAHIM ALI, Cairo University
- Investigators
- ZIZI MOHAMMED I ALI, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587102
- Sponsor's protocol ID
- VIYOBURN
- Status last verified
- May 2021
- First submitted
- 18 Aug 2020
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Body Vibration Training for Diabetic Patients With Burn Injury: RCT
- ClinicalTrials.gov ID
- NCT04587102
- Acronym / sponsor ID
- VIYOBURN
- Conditions
- Burn Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 12 Sep 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 14 Oct 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.
Burn injury as well as diabetes mellitus (DM) induce physical functional and psychological impairments. Lower limb burn involving Foot are still a challenging heath condition because of its important sensory role. Balance is disturbed either in patients with lower limb burn injury or diabetic patients. This study aime to compare between the effects whole body vibrational training and Yoga exercises on postural balance, and Activities-specific Balance Confidence in in type II diabetic Patients with foot burn
Detailed description
Thirty eight diabetic patients (17 male, 21female) with foot burn injury, with their age ranged from 40 to 55 years. They will randomly assigned into two equal groups. Group (A) will receive low vibrational training in the form of whole body vibration for 8 weeks (n=19), while group (B) the control group for 8 weeks (n=19) in addition both groups will receive their routine medical care and physical therapy rehabilitation including balancing exercises. Dynamic balance will be evaluated through Biodex balance system (BBS);and balance confidence will be measured by the Activities-specific Balance Confidence Scale (ABC) before the starting and after the end of treatment for all patients in both groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- vibration Group (A) will receive low vibrational training in the form of whole body vibration for 8 weeks , while group B is the control, both groups will receive their routine medical care and physical therapy rehabilitation.
| Arm | Type | Receives |
|---|---|---|
| whole body viberation :group A | Active comparator | Other: whole body viberation, Other: Traditional program(balance exercises and resisted exercises)will receive low vibrational training in the form of whole body vibration for 8 weeks |
| control group (B) | Active comparator | Other: Traditional program(balance exercises and resisted exercises)control |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- chronic lower limb burns injury for more than 6 months
- Total body surface area (TBSA) burnt ≤ 30%.;
Key exclusion criteria (7 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 |
|---|---|---|
| whole body viberationAlso: WBVvibration training in the form of whole body vibration for 20-30 minutes per session, 3 sessions per week for 8 weeks. The vibration training was performed on a whole body vibration platform | Other | whole body viberation :group A |
| Traditional program(balance exercises and resisted exercises)balance exercises and resisted exercises | Other | control group (B), whole body viberation :group A |
Primary outcome
Dynamic balance assessment
Time frame: Change from Baseline at balance scores at 8 weeks
Biodex Balance System was used to measure the dynamic balance of each patient in both groups (A and B) before and after 8 weeks of treatment. The system has a movable balance platform that permits about 20◦ tilt in 360◦ range, and is interfaced with computer software for objective balance assessment. It measures the ability of the patient to control the platform's tilting angle, which is quantified as a variation from the center, as well as the deflection degree over time at different stability levels
1 secondary outcome
The Activities-specific Balance
Time frame: Change from Baseline at Activities-specific Balance scores at 8 weeks
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 19 May 2021.
- Individual participant dataSharing planned: No
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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.
ZIZI MOHAMMED I ALI principal investigator
Cairo University
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole body viberation and Traditional program(balance exercises and resisted exercises) in people with Burn Injury, run by Cairo University at 3 sites in 2 countries.
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 2 inclusion and 7 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 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt, Saudi Arabia. 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?
Dynamic balance assessment (time frame: Change from Baseline at balance scores at 8 weeks). 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 19 May 2021.