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

NCT ID: NCT06284733

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 115 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-22
• Study Completion Date: 2024-06-10

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.

Conditions

Amputation; Traumatic, Leg, Lower

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

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

Group Type: EXPERIMENTAL

Whole-body vibration plus conservative care

Intervention Type: 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.

conservative care

Intervention Type: 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 B (visual feedback-deprived and WBV (VFD WBV) (30 HZ,4 mm ,eyes close)

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

Group Type: EXPERIMENTAL

Whole-body vibration plus conservative care

Intervention Type: 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.

conservative care

Intervention Type: 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 C(control group (0 Hz, eyes open)

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

Group Type: SHAM_COMPARATOR

conservative care

Intervention Type: 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.

Interventions

Whole-body vibration plus 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.

Intervention Type: DEVICE

conservative care

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MTI University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Mohamed Ahmed Abd El hady El Fahl,ph.d

lectrurer of physical therapy for general surgery and dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ahmed Mohamed Ahmed Abdelhady

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 39902775 (View on PubMed)

Other Identifiers

P.T.REC/012/004874

Identifier Type: -

Identifier Source: org_study_id