Clinical trial NCT06284733: Whole-body Vibration Without Visual Feedback on Postural Steadiness in Unilateral Trans-femoral Traumatic Amputees
Official title: Whole-body Vibration Without Visual Feedback on Postural Steadiness in Unilateral Trans-femoral Traumatic Amputees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation; Traumatic, Leg, Lower
Keywords: postural stability
amputee
Lead sponsor: MTI University
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 115
Sex: ALL
Minimum age (years): 40
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: They will be assigned into three equal groups:
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Prosthetic leg stability test
timeFrame: base line and after 12 weeks.
Secondary outcomes:
measure: Sway Index
timeFrame: base line after 12 weeks
measure: Limits of Stability Test
timeFrame: base line after 12 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Mohamed Ahmed Abdelhady
Study officials:
References: