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

NCT06284733 | Completed

• 1 other identifier: P.T.REC/012/004874
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation; Traumatic, Leg, Lower

Keywords

postural stability; amputee

Outcome Measures

Primary Outcomes (1)

• 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

  base line and after 12 weeks.

Secondary Outcomes (2)

• Sway Index

  base line after 12 weeks

• Limits of Stability Test

  base line after 12 weeks

Study Arms (3)

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.

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.

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.

Other: conservative care

Interventions

Whole-body vibration plus conservative care DEVICE

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.

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 care OTHER

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.

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)

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MTI University: lead

Study Sites (1)

Ahmed Mohamed Ahmed Abdelhady

Cairo, Egypt

Location

Related Publications (1)

• 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.

  PMID: 39902775 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lectrurer of physical therapy for general surgery and dermatology

Model Details: They will be assigned into three equal groups:

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 29, 2024
• Study Start: February 22, 2024
• Primary Completion: May 29, 2024
• Study Completion: June 10, 2024
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)