AmputeesNCT04114175
Spinal Stabilization Exercises in Individuals With Transtibial Amputatıon
A study testing Exercise BE and Exercise BE+SS in people with Amputees and Exercise Training, run by Baskent University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Amputees, Exercise Training, Physiotherapy
- What is being tested?
- Exercise BE and Exercise BE+SS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2019to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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'.
- Conditions
- Amputees, Exercise Training, Physiotherapy, Energy Metabolism
- Being tested
- Exercise BE, Exercise BE+SS
- Keywords
- amputees, rehabilitation, energy expenditure, deep muscles of the back
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise BEOther
Basic exercises related to amputation will be applied
Exercise BE+SSOther
Basic exercises related to amputation + Spinal stabilization exercises will be applied
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | People with unilateral transtibial amputation. Participants will be provided from the sample group according to the randomization. Receives: Other: Exercise BE |
| Spinal Stabilization Group | Experimental | People with unilateral transtibial amputation. Participants will be provided from the sample group according to the randomization. Receives: Other: Exercise BE+SS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure and exercise capacity
Assessement will be with the exercise tester (COSMED, Fitmate Pro, Rome, Italy) during the 6 Minute Step Test .
Measured: 6 minutes
Secondary outcomes (3)
Fatigue
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).
Measured: 20 seconds
Strength of deep spinal muscles
Assessement will be with "Stabilizer".
Measured: 3 minutes
Mobility
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).
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start1 Sep 2019
- Primary completion1 Sep 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputeesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Principal investigator, Senay Cerezci Duygu, Baskent University
- Investigators
- Fatih Erbahceci, Prof, Study chair, Hacettepe UniversitySenay Cerezci Duygu, MSc, Study director, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114175
- Sponsor's protocol ID
- KA19/143
- Status last verified
- Aug 2023
- First submitted
- 1 Oct 2019
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Spinal Stabilization Exercises on Energy Expenditure in Individuals With Transtibial Amputatıon
- ClinicalTrials.gov ID
- NCT04114175
- Acronym / sponsor ID
- KA19/143
- Conditions
- Amputees, Exercise Training, Physiotherapy, Energy Metabolism
- Keywords
- amputees, rehabilitation, energy expenditure, deep muscles of the back
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Exercise BEPeople with unilateral transtibial amputation. Participants will be provided from the sample group according to the randomization. |
| Spinal Stabilization Group | Experimental | Other: Exercise BE+SSPeople with unilateral transtibial amputation. Participants will be provided from the sample group according to the randomization. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise BEBasic exercises related to amputation will be applied | Other | Control Group |
| Exercise BE+SSBasic exercises related to amputation + Spinal stabilization exercises will be applied | Other | Spinal Stabilization Group |
Primary outcome
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 .
3 secondary outcomes
Fatigue
Time frame: 20 seconds
Strength of deep spinal muscles
Time frame: 3 minutes
Mobility
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fatih Erbahceci, Prof study chair
Hacettepe University
Senay Cerezci Duygu, MSc study director
Baskent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise BE and Exercise BE+SS in people with Amputees and Exercise Training, run by Baskent University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Energy expenditure and exercise capacity (time frame: 6 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.