Whole-body Vibration Without Visual Feedback on Postural Steadiness in Unilateral Trans-femoral Traumatic Amputees

MTI University

Status: Completed

Conditions: Amputation; Traumatic, Leg, Lower

Treatments: Other: conservative care; Device: Whole-body vibration plus conservative care

Study type: Interventional

Funder types: Other

Identifiers

NCT06284733

P.T.REC/012/004874

Details and patient eligibility

About

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.

Full 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.

Enrollment: 115 patients

Sex: All

Ages: 40 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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115 participants in 3 patient groups

Group A (WBV group)(30 HZ,4 mm ,eyes open)

Experimental group

Description:

This group includes 36 patients with unilateral trans-femoral traumatic amputation; they will receive WBV and conservative care.

Treatment:

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 group

Description:

This group includes 36 patients with unilateral trans-femoral traumatic amputation; they will receive visual feedback-deprived plus WBV (VFDWBV) and conservative care.

Treatment:

Device: Whole-body vibration plus conservative care

Other: conservative care

Group C(control group (0 Hz, eyes open)

Sham Comparator group

Description:

This group includes 36 patients with unilateral trans-femoral traumatic amputation; they will receive conservative care.

Treatment:

Other: conservative care