Spinal Stabilization Exercises in Individuals With Transtibial Amputatıon

NCT04114175 | Completed

• 1 other identifier: KA19/143
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Lower extremity amputation causes rapid changes in musculoskeletal system. With the effect of these changes, the energy requirement for prosthetic ambulance is much higher than normal ambulance. Although methods such as the reduction of the segmental load of the prosthesis and the preference of the different prosthetic components for energy expenditure have been emphasized, the effect of exercise types has not been investigated in our knowledge. Therefore, the aim of the current study is to investigate the effect of spinal (Core) stabilization exercises on energy expenditure in combination with the classical physiotherapy program in patients with unilateral transtibial amputation. Individuals with transtibial amputation included in the study will be randomly divided into two groups. In group 1, basic exercises related to amputation will be applied for 8 weeks and in group 2 basic exercises with spinal stabilization exercises will be applied to the individuals. At the beginning and at the end of the exercise intervention, energy expenditure and exercise capacity will be evaluated by a portable exercise test device during '6 Minutes Step Test'; fatigue assessment will be done before and after 6 Minutes Step Test with 'Modified Borg Scale'; the strength of deep spinal muscles will be evaluated with 'Stabilizer'; dynamic balance and functional mobility will be evaluated by 'Timed Up \& Go' Test; and the effect of the prosthesis on mobility will be evaluated by the sub-scale 'Mobility' of 'Prosthetic Evaluation Questionnaire'.

Conditions

Amputees; Exercise Training; Physiotherapy; Energy Metabolism

Keywords

amputees; rehabilitation; energy expenditure; deep muscles of the back

Outcome Measures

Primary Outcomes (1)

• Energy expenditure and exercise capacity

  Assessement will be with the exercise tester (COSMED, Fitmate Pro, Rome, Italy) during the 6 Minute Step Test .

  6 minutes

Secondary Outcomes (3)

• Fatigue

  20 seconds

• Strength of deep spinal muscles

  3 minutes

• Mobility

  5 minutes

Study Arms (2)

Control Group

ACTIVE COMPARATOR

People with unilateral transtibial amputation. Participants will be provided from the sample group according to the randomization.

Other: Exercise BE

Spinal Stabilization Group

EXPERIMENTAL

People with unilateral transtibial amputation. Participants will be provided from the sample group according to the randomization.

Other: Exercise BE+SS

Interventions

Exercise BE OTHER

Basic exercises related to amputation will be applied

Control Group

Exercise BE+SS OTHER

Basic exercises related to amputation + Spinal stabilization exercises will be applied

Spinal Stabilization Group

Eligibility Criteria

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

You may qualify if:

• Having unilateral transtibial amputation of at least 6 months in which the stump volume becomes stable,
• Being prosthetic users (For homogenization of the groups in terms of external support used, individuals with transitibial amputation included in the study should use total contact socket and carbon foot prosthesis systems - Pin System, Passive Vacuum System or Active Vacuum System),
• Having at least "four" quadriceps and hamstring muscle strength in the amputated limb according to Lovett's manual muscle test method.

You may not qualify if:

• Having any disadvantage about prosthetic device usage in terms of stump length, shape and edema,
• Having movement limitation,
• Having phantom pain in the stump,
• Having any discomfort or health problem (cardiopulmonary, neurological or orthopedic problems) that may affect gait other than amputation,
• Having multiple extremity loss.

Sponsors & Collaborators

• Baskent University: lead
• Hacettepe University: collaborator

Study Sites (1)

Baskent University

Ankara, Etimesgut, 06790, Turkey (Türkiye)

Location

Study Officials

• Fatih Erbahceci, Prof

  Hacettepe University

  STUDY CHAIR

• Senay Cerezci Duygu, MSc

  Baskent University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 3, 2019
• Study Start: September 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2021
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)