An interventional study of Whole-body vibration plus conservative care and conservative care in Amputation; Traumatic, Leg, Lower, sponsored by MTI University. Completed at 1 site in Egypt. Open to participants aged 40 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by MTI University · Not applicable, Interventional, and Treatment
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.
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.
112 studies on the registry are indexed under Amputation, Traumatic; 24 are open to participants now.
This study's enrollment of 115 is above the median of 15 across 75 interventional studies indexed under Amputation, Traumatic.
Browse Amputation, Traumatic studies →MTI University is the lead sponsor of 61 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group includes 36 patients with unilateral trans-femoral traumatic amputation; they will receive WBV and conservative care.
Device: Whole-body vibration plus conservative care · Other: conservative care
This group includes 36 patients with unilateral trans-femoral traumatic amputation; they will receive visual feedback-deprived plus WBV (VFDWBV) and conservative care.
Device: Whole-body vibration plus conservative care · Other: conservative care
This group includes 36 patients with unilateral trans-femoral traumatic amputation; they will receive conservative care.
Other: conservative care
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.
1. 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.
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
Time frame: base line and after 12 weeks.
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.
Time frame: 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.
Time frame: base line after 12 weeks
Plan to share: No
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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