COMPARISON OF THE EFFECTS OF TELEREHABILITATION AND FACE-TO-FACE SPINAL STABILIZATION TRAININGS ON GAIT BIOMECHANICS, BALANCE AND JOINT POSITION SENSE IN TRANSTIBIAL AMPUTEES: A RANDOMIZED CONTROLLED, SINGLE BLIND STUDY

NCT05569967 | Completed

• 1 other identifier: 2022-986/12
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

After transtibial amputations, biomechanical changes in the trunk, pelvis, and lumbar region cause asymmetrical strength and core muscle activation on the amputated side, which negatively affects the gait biomechanics of individuals. However, routine treatment programs do not use treatment approaches based on the core region. This study will focus on the effects of telerehabilitation and face-to-face spinal stabilization exercise training on gait, balance, joint position sense, core muscle function, and perceived mobility in transtibial amputees, after treatment, and after long-term follow-up.

Conditions

Amputation

Outcome Measures

Primary Outcomes (1)

• gait speed

  Participants will be asked to walk on flat ground for 10 meters. At this time, the speed will be evaluated by the BTS G-Walk sensor.

  Change from baseline at 8 weeks and 5 months

Secondary Outcomes (14)

• spatial parameter of gait

  Change from baseline at 8 weeks and 5 months

• temporal parameter of gait

  Change from baseline at 8 weeks and 5 months

• Dynamic Balance

  Change from baseline at 8 weeks and 5 months

• Balance confidence

  Change from baseline at 8 weeks and 5 months

• Core Muscle Strength

  Change from baseline at 8 weeks and 5 months

Study Arms (2)

Group 1

EXPERIMENTAL

Individuals in this group will receive spinal stabilization training through telerehabilitation.

Other: Spinal stabilization training through telerehabilitation

Group 2

ACTIVE COMPARATOR

Individuals in this group will receive spinal stabilization training face-to-face.

Other: Spinal stabilization training face-to-face

Interventions

Spinal stabilization training through telerehabilitation OTHER

Individuals in both groups will receive spinal stabilization training 3 times a week for 8 weeks.

Group 1

Spinal stabilization training face-to-face OTHER

Individuals in both groups will receive spinal stabilization training 3 times a week for 8 weeks.

Group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who use total contact sockets
• have been using prostheses for at least 1 year,
• can walk independently without a walking aid
• functionally at least K2

You may not qualify if:

• Bilateral amputation
• Upper extremity amputation
• Neurological problems
• Other orthopedic problems

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Yildirim Beyazit University

Ankara, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 6, 2022
• Study Start: October 25, 2022
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

TU (1)