- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04114175
Spinal Stabilization Exercises in Individuals With Transtibial Amputatıon
August 28, 2023 updated by: Senay Cerezci Duygu, Baskent University
The Effects of Spinal Stabilization Exercises on Energy Expenditure in Individuals With Transtibial Amputatıon
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'.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Senay Cerezci Duygu, MSc
- Phone Number: 05369128768
- Email: senaycerezci@gmail.com
Study Locations
-
-
Etimesgut
-
Ankara, Etimesgut, Turkey, 06790
- Başkent University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control Group
People with unilateral transtibial amputation.
Participants will be provided from the sample group according to the randomization.
|
Basic exercises related to amputation will be applied
|
Experimental: Spinal Stabilization Group
People with unilateral transtibial amputation.
Participants will be provided from the sample group according to the randomization.
|
Basic exercises related to amputation + Spinal stabilization exercises will be applied
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Energy expenditure and exercise capacity
Time Frame: 6 minutes
|
Assessement will be with the exercise tester (COSMED, Fitmate Pro, Rome, Italy) during the 6 Minute Step Test .
|
6 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fatigue
Time Frame: 20 seconds
|
Assessement will be with "Modified Borg Scale" after 6 Minute Step Test.
Pariticipants were shown the Modified Borg Scale, which is a vertical scale from 0 to 10 in which numbers are anchored with corresponding verbal expressions of progressively increasing intensity.
The patients were asked to rate their fatigue by selecting the number with the corresponding words that most appropriately described their sensation of fatigue.
The minimum value that can be obtained as a result of the evaluation is 0 (Nothing at all), the maximum value is 10 (Maximal).
|
20 seconds
|
Strength of deep spinal muscles
Time Frame: 3 minutes
|
Assessement will be with "Stabilizer".
|
3 minutes
|
Mobility
Time Frame: 5 minutes
|
Prosthesis Evaluation Questionnaire (PEQ) was designed as a self-report visual analog scale style questionnaire with scores expressed in millimeters (0-100 mm).
PEQ was previously translated to Turkish language, and it was proven to be valid and reliable.
The questions of the PEQ are organized into nine functional domain scales, each reflecting a major area of concern for persons with amputations, such as "mobility".
Each domain scale can be used and scored independent of the others.
All subscales are scored between 0 and 100 (for example, in mobility subscale higher scores indicate higher mobility).
In mobility subscale there are 13 questions.
The minimum value that can be obtained as a result of the evaluation is 0 (minimum mobility), the maximum value is 130 (maximum mobility).
|
5 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Fatih Erbahceci, Prof, Hacettepe University
- Study Director: Senay Cerezci Duygu, MSc, Başkent University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2019
Primary Completion (Actual)
September 1, 2021
Study Completion (Actual)
October 1, 2021
Study Registration Dates
First Submitted
October 1, 2019
First Submitted That Met QC Criteria
October 2, 2019
First Posted (Actual)
October 3, 2019
Study Record Updates
Last Update Posted (Actual)
August 29, 2023
Last Update Submitted That Met QC Criteria
August 28, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- KA19/143
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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