Amputation; Traumatic, Leg, LowerNCT06284733
Whole-body Vibration Without Visual Feedback on Postural Steadiness in Unilateral Trans-femoral Traumatic Amputees
A study testing Whole-body vibration plus conservative care and conservative care in people with Amputation; Traumatic, Leg, Lower, run by MTI University at 1 site in Egypt.
Trial summary
This study will investigate the effects of Whole-body vibration without visual feedback on postural steadiness in unilateral trans-femoral traumatic amputees. This study will be carried out at the outpatient clinic of the faculty of physical therapy, modern university for technology and information, and El Wafaa wel… Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Amputation; Traumatic, Leg, Lower
- What is being tested?
- Whole-body vibration plus conservative care and conservative care
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Feb 2024to 10 Jun 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 40 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 40 to 55 years of age.
- Residual femoral length from ischial tuberosity to the end of the limb with distal soft tissue compressed (15-35 cm)
- Unilateral trans-femoral traumatic amputation with single-axis mechanical knees, axial foot (single axis).
- Able to walk without the use of any assistive device; subjects must have obtained a score of > 5 for Houghton Scale to indicate active use of prosthesis and > 41 for Berg Balance Scale (BBS).
- Medicare level 3 (community) ambulatory or above.
- Ability to descend stairs and hills without caregiver and assistive devices.
- Be able to independently provide informed consent.
- Be willing to comply with study procedures.
Who cannot join
- Reduced somatosensory sensibility of the non-affected limb, ulceration or pain at the stump
- the amputation was of vascular origin
- Poor fittings of prosthesis
- Visual or vestibular impairment (vertigo or dizziness)
- Lower limb musculoskeletal injury and other neurological deficits
Trial locations and contacts
1 site in 1 country.
About this study
This study will investigate the effects of Whole-body vibration without visual feedback on postural steadiness in unilateral trans-femoral traumatic amputees. This study will be carried out at the outpatient clinic of the faculty of physical therapy, modern university for technology and information, and El Wafaa wel Amal hospital.
All participants will sign a written consent form after receiving full information about the purpose of the study, procedure, possible benefits, privacy, and use of data.
Read the detailed description
The postural steadiness is the dynamics of the postural control system associated with maintaining balance during quiet standing and usually assessed by the displacement of the centre of pressure (COP).
The control of posture is maintained by a complex sensory-motor system, which integrates information from the visual, proprioceptive, vestibular and somato-sensory systems. In the case of a unilateral trans femoral amputee, the individual becomes structurally asymmetrical, as there is an altered sensation and a loss of musculature on the amputated side. Whole-body vibration (WBV) is a therapeutic method that exposes the entire body to mechanical oscillations while the patient stands or sits on a vibrating platform. This method was used in rehabilitation to improve muscle function, joint stability, balance control and to reduce the risk of falling.
Whole-body vibration (WBV) training helps to improve the dysfunction of the nervous system and musculoskeletal system diseases, to prevent and relieve osteoporosis in the elderly, and to promote sports injury recovery and improve sports performance. But till now there is no judgment concerning the difference and significance of Whole-body vibration without visual feedback on postural steadiness in unilateral trans-femoral traumatic amputees.
- Conditions
- Amputation; Traumatic, Leg, Lower
- Being tested
- Whole-body vibration plus conservative care, conservative care
- Keywords
- postural stability, amputee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-body vibration plus conservative careDevice
Whole-body vibration (WBV) is a therapeutic method that exposes the entire body to mechanical oscillations while the patient stands or sits on a vibrating platform. This method was used in rehabilitation to improve muscle function, joint stability, balance control and to reduce the risk of falling.
conservative careOther
- Stretching and ROM exercises daily to make sure that the patient can straighten hip; this makes walking, and even lying in bed, more comfortable.
- Resting hip on a pillow, as this promotes a hip flexion contracture
- A pillow between legs, as this lengthens the inner thigh muscle that helps to keep legs together while walking, and shortens the outer thigh muscles so that walking and standing with feet apart.
- Regular skin care.
- Regular prosthetic care.
| Study group | Role | What they receive |
|---|---|---|
| Group A (WBV group)(30 HZ,4 mm ,eyes open) | Experimental | This group includes 36 patients with unilateral trans-femoral traumatic amputation; they will receive WBV and conservative care. Receives: Device: Whole-body vibration plus conservative care; Other: conservative care |
| Group B (visual feedback-deprived and WBV (VFD WBV) (30 HZ,4 mm ,eyes close) | Experimental | This group includes 36 patients with unilateral trans-femoral traumatic amputation; they will receive visual feedback-deprived plus WBV (VFDWBV) and conservative care. Receives: Device: Whole-body vibration plus conservative care; Other: conservative care |
| Group C(control group (0 Hz, eyes open) | Sham comparator | This group includes 36 patients with unilateral trans-femoral traumatic amputation; they will receive conservative care. Receives: Other: conservative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthetic leg stability test
Prior to testing, the subject will be asked to center the foot on the platform in a position that will be level and stable. This foot placement will maintained through -out all 3 trials for the prosthetic leg. This position will be used as the level reference point from which degree of displacement was measured. The subject will instructed to stand on foot with the knee slightly flexed (15°) on the platform, with the contralateral knee flexed to 90° for 20 seconds (test period). Level 8 will be selected for use during testing
Measured: base line and after 12 weeks.
Secondary outcomes (2)
Sway Index
The CTSIB (Modified Clinical Test of Sensory Interaction on Balance) is a standard test for postural steadiness on different surfaces. This test was designed to assess the patient's ability to integrate sensory information to maintain body equilibrium.
Measured: base line after 12 weeks
Limits of Stability Test
The subjects will be asked to move directly toward the target, the best expected outcome was a straight path. During this test, 8 targets will be presented in each direction, and the subjects were randomly given instructions. The subjects will be requested to move their centre of gravity toward the targets, touch them, and then return to the center.
Measured: base line after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start22 Feb 2024
- Primary completion29 May 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amputation; Traumatic, Leg, LowerStudies 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
- They will be assigned into three equal groups:
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- MTI University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d, MTI University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06284733
- Sponsor's protocol ID
- P.T.REC/012/004874
- Status last verified
- Jul 2024
- First submitted
- 19 Feb 2024
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elfeky HM, Elfahl AM, Mohamed HS. Whole-Body Vibration Without Visual Feedback on Postural Steadiness in Unilateral Trans-Femoral Traumatic Amputees: A Randomized Controlled Trial. Physiother Res Int. 2025 Apr;30(2):e70031. doi: 10.1002/pri.70031.
PubMed 39902775
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole-body Vibration Without Visual Feedback on Postural Steadiness in Unilateral Trans-femoral Traumatic Amputees
- ClinicalTrials.gov ID
- NCT06284733
- Acronym / sponsor ID
- P.T.REC/012/004874
- Conditions
- Amputation; Traumatic, Leg, Lower
- Keywords
- postural stability, amputee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- MTI UniversityUniversity, hospital or other
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- 29 May 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 29 Feb 2024 (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 investigate the effects of Whole-body vibration without visual feedback on postural steadiness in unilateral trans-femoral traumatic amputees. This study will be carried out at the outpatient clinic of the faculty of physical therapy, modern university for technology and information, and El Wafaa wel Amal hospital.
All participants will sign a written consent form after receiving full information about the purpose of the study, procedure, possible benefits, privacy, and use of data.
Detailed description
The postural steadiness is the dynamics of the postural control system associated with maintaining balance during quiet standing and usually assessed by the displacement of the centre of pressure (COP).
The control of posture is maintained by a complex sensory-motor system, which integrates information from the visual, proprioceptive, vestibular and somato-sensory systems. In the case of a unilateral trans femoral amputee, the individual becomes structurally asymmetrical, as there is an altered sensation and a loss of musculature on the amputated side. Whole-body vibration (WBV) is a therapeutic method that exposes the entire body to mechanical oscillations while the patient stands or sits on a vibrating platform. This method was used in rehabilitation to improve muscle function, joint stability, balance control and to reduce the risk of falling.
Whole-body vibration (WBV) training helps to improve the dysfunction of the nervous system and musculoskeletal system diseases, to prevent and relieve osteoporosis in the elderly, and to promote sports injury recovery and improve sports performance. But till now there is no judgment concerning the difference and significance of Whole-body vibration without visual feedback on postural steadiness in unilateral trans-femoral traumatic amputees.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- They will be assigned into three equal groups:
| Arm | Type | Receives |
|---|---|---|
| Group A (WBV group)(30 HZ,4 mm ,eyes open) | Experimental | Device: Whole-body vibration plus conservative care, Other: conservative careThis group includes 36 patients with unilateral trans-femoral traumatic amputation; they will receive WBV and conservative care. |
| Group B (visual feedback-deprived and WBV (VFD WBV) (30 HZ,4 mm ,eyes close) | Experimental | Device: Whole-body vibration plus conservative care, Other: conservative careThis group includes 36 patients with unilateral trans-femoral traumatic amputation; they will receive visual feedback-deprived plus WBV (VFDWBV) and conservative care. |
| Group C(control group (0 Hz, eyes open) | Sham comparator | Other: conservative careThis group includes 36 patients with unilateral trans-femoral traumatic amputation; they will receive conservative care. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 40 to 55 years of age.
- Residual femoral length from ischial tuberosity to the end of the limb with distal soft tissue compressed (15-35 cm)
- Unilateral trans-femoral traumatic amputation with single-axis mechanical knees, axial foot (single axis).
- Able to walk without the use of any assistive device; subjects must have obtained a score of > 5 for Houghton Scale to indicate active use of prosthesis and > 41 for Berg Balance Scale (BBS).
- Medicare level 3 (community) ambulatory or above.
Key exclusion criteria (5 listed)
- Reduced somatosensory sensibility of the non-affected limb, ulceration or pain at the stump
- the amputation was of vascular origin
- Poor fittings of prosthesis
- Visual or vestibular impairment (vertigo or dizziness)
- Lower limb musculoskeletal injury and other neurological deficits
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 plus conservative careWhole-body vibration (WBV) is a therapeutic method that exposes the entire body to mechanical oscillations while the patient stands or sits on a vibrating platform. This method was used in rehabilitation to improve muscle function, joint stability, balance control and to reduce the risk of falling. | Device | Group A (WBV group)(30 HZ,4 mm ,eyes open), Group B (visual feedback-deprived and WBV (VFD WBV) (30 HZ,4 mm ,eyes close) |
| conservative care1. Stretching and ROM exercises daily to make sure that the patient can straighten hip; this makes walking, and even lying in bed, more comfortable. 2. Resting hip on a pillow, as this promotes a hip flexion contracture 3. A pillow between legs, as this lengthens the inner thigh muscle that helps to keep legs together while walking, and shortens the outer thigh muscles so that walking and standing with feet apart. 4. Regular skin care. 5. Regular prosthetic care. | Other | Group A (WBV group)(30 HZ,4 mm ,eyes open), Group B (visual feedback-deprived and WBV (VFD WBV) (30 HZ,4 mm ,eyes close), Group C(control group (0 Hz, eyes open) |
Primary outcome
Prosthetic leg stability test
Time frame: base line and after 12 weeks.
Prior to testing, the subject will be asked to center the foot on the platform in a position that will be level and stable. This foot placement will maintained through -out all 3 trials for the prosthetic leg. This position will be used as the level reference point from which degree of displacement was measured. The subject will instructed to stand on foot with the knee slightly flexed (15°) on the platform, with the contralateral knee flexed to 90° for 20 seconds (test period). Level 8 will be selected for use during testing
2 secondary outcomes
Sway Index
Time frame: base line after 12 weeks
Limits of Stability Test
Time frame: base line after 12 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 30 Jul 2024.
- Derived from this study: PubMed 39902775Elfeky HM, Elfahl AM, Mohamed HS. Whole-Body Vibration Without Visual Feedback on Postural Steadiness in Unilateral Trans-Femoral Traumatic Amputees: A Randomized Controlled Trial. Physiother Res Int. 2025 Apr;30(2):e70031. doi: 10.1002/pri.70031.
- 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.
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 plus conservative care and conservative care in people with Amputation; Traumatic, Leg, Lower, run by MTI 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 8 inclusion and 5 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 30 Jul 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. Some participants in this study may receive a placebo. 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?
Prosthetic leg stability test (time frame: base line and after 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06284733, which also lists 1 linked publication.
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 30 Jul 2024.