AmputationNCT05569967
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
A study testing Spinal stabilization training through telerehabilitation and Spinal stabilization training face-to-face in people with Amputation, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation
- What is being tested?
- Spinal stabilization training through telerehabilitation and Spinal stabilization training face-to-face
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Oct 2022to 30 Mar 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Bilateral amputation
- Upper extremity amputation
- Neurological problems
- Other orthopedic problems
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Spinal stabilization training through telerehabilitation, Spinal stabilization training face-to-face
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal stabilization training through telerehabilitationOther
Individuals in both groups will receive spinal stabilization training 3 times a week for 8 weeks.
Spinal stabilization training face-to-faceOther
Individuals in both groups will receive spinal stabilization training 3 times a week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Individuals in this group will receive spinal stabilization training through telerehabilitation. Receives: Other: Spinal stabilization training through telerehabilitation |
| Group 2 | Active comparator | Individuals in this group will receive spinal stabilization training face-to-face. Receives: Other: Spinal stabilization training face-to-face |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline at 8 weeks and 5 months
Secondary outcomes (14)
spatial parameter of gait
Participants will be asked to walk on flat ground for 10 meters. At this time, the spatial variable of gait will be evaluated by the BTS G-Walk sensor.
Measured: Change from baseline at 8 weeks and 5 months
temporal parameter of gait
Participants will be asked to walk on flat ground for 10 meters. At this time, the temporal variable of gait will be evaluated by the BTS G-Walk sensor.
Measured: Change from baseline at 8 weeks and 5 months
Dynamic Balance
Dynamic balance; will be evaluated with the "Four Square Step Test", which is a valid and reliable measure in the evaluation of gait, mobility and dynamic balance. The time to complete four frames is recorded. If the duration is more than 24 seconds, it is considered that there is a risk of falling.
Measured: Change from baseline at 8 weeks and 5 months
Balance confidence
Balance confidence of individuals will be evaluated with the "Activity-Specific Balance Confidence Scale". On this scale, individuals score their balance confidence between 0% and 100% during various ambulatory activities. A mean score of 50% or less indicates low physical function, 50-80% indicates moderate physical function, and 80% or higher indicates high physical function.
Measured: Change from baseline at 8 weeks and 5 months
Core Muscle Strength
The strength of the core muscles will be evaluated using "The Stabilizer Pressure Biofeedback Unit". The pressure values for the measurement will be recorded 3 times in a row, at the beginning and end of the 10-second contraction, and the average value will be taken.
Measured: Change from baseline at 8 weeks and 5 months
Core Muscle Endurance- Trunk Flexor
The trunk flexor test will be performed with the arms crossed over the thorax, the trunk at 55 degrees of flexion, and the knees and hips flexed to 90 degrees. The test will be finished when the participant is unable to maintain the position. The time will be recorded.
Measured: Change from baseline at 8 weeks and 5 months
Core Muscle Endurance- Trunk Extansor
The trunk extensor test will be performed in the prone position, with the pelvis, hips and knees fixed to the bed. The participant will be asked to cross his arms over his body and position his body horizontally. The test will be finished when the participant is unable to maintain the horizontal position. The time will be recorded.
Measured: Change from baseline at 8 weeks and 5 months
Core Muscle Endurance- Side Bridge
While the participants are in the side-lying position, they will raise their hips and align their bodies in a straight line by getting support from their feet and elbows. The time will be recorded by asking them to maintain the position as much as possible.
Measured: Change from baseline at 8 weeks and 5 months
Perceived Mobility
The Prosthetic Limb Users Survey of Mobility (PLUS-M) Short Form will be used. The questionnaire consists of a total of 12 items, each of which is evaluated over 0-5 points. All items evaluate the degree of ability of the individual to perform the activity rather than the actual performance of the individual, and reflect the difficulty experienced by the individual while performing the activity. Higher scores indicate better mobility.
Measured: Change from baseline at 8 weeks and 5 months
Joint Position Sense-Knee
It will be evaluated with a dual digital inclinometer (ACUMAR™).While the participants are in the prone position, the inclinometer will be placed on the femur and fibula and they will be asked to flex the knee at 40 degrees. It will be asked to feel the angle completely by keeping it in this position for a certain period of time and then return to the neutral position. The patient will then be asked to find the target angle. The difference between the target angle and the obtained angle will be determined as an absolute value and recorded in degrees.
Measured: Change from baseline at 8 weeks and 5 months
Joint Position Sense-Trunk
It will be evaluated with a dual digital inclinometer (ACUMAR™). The test will be performed in a standing position with eyes closed, barefoot on a hard floor, with the support surface shoulder-width apart. The inclinometer will be fixed on the T1 and S1 spinous processes and 30 degrees of trunk flexion will be required. It will be asked to feel the angle completely by keeping it in this position for a certain period of time and then return to the neutral position. The patient will then be asked to find the target angle. The difference between the target angle and the obtained angle will be determined as an absolute value and recorded in degrees.
Measured: Change from baseline at 8 weeks and 5 months
pelvic parameter of gait
Participants will be asked to walk on flat ground for 10 meters. At this time, the pelvic parameter of gait will be evaluated by the BTS G-Walk sensor.
Measured: Change from baseline at 8 weeks and 5 months
Step symmetry
The time-distance characteristics of the gait will be used to calculate the gait symmetry. The step time of the non-amputee will be calculated in proportion to the amputated side.
Measured: Change from baseline at 8 weeks and 5 months
Stance symmetry
The time-distance characteristics of the gait will be used to calculate the gait symmetry. The stance time of the non-amputee will be calculated in proportion to the amputated side.
Measured: Change from baseline at 8 weeks and 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start25 Oct 2022
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569967
- Sponsor's protocol ID
- 2022-986/12
- Status last verified
- Dec 2024
- First submitted
- 4 Oct 2022
- Last updated
- 27 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05569967
- Acronym / sponsor ID
- 2022-986/12
- Conditions
- Amputation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 6 Oct 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Spinal stabilization training through telerehabilitationIndividuals in this group will receive spinal stabilization training through telerehabilitation. |
| Group 2 | Active comparator | Other: Spinal stabilization training face-to-faceIndividuals in this group will receive spinal stabilization training face-to-face. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Bilateral amputation
- Upper extremity amputation
- Neurological problems
- Other orthopedic problems
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 |
|---|---|---|
| Spinal stabilization training through telerehabilitationIndividuals in both groups will receive spinal stabilization training 3 times a week for 8 weeks. | Other | Group 1 |
| Spinal stabilization training face-to-faceIndividuals in both groups will receive spinal stabilization training 3 times a week for 8 weeks. | Other | Group 2 |
Primary outcome
gait speed
Time frame: Change from baseline at 8 weeks and 5 months
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.
14 secondary outcomes
spatial parameter of gait
Time frame: Change from baseline at 8 weeks and 5 months
temporal parameter of gait
Time frame: Change from baseline at 8 weeks and 5 months
Dynamic Balance
Time frame: Change from baseline at 8 weeks and 5 months
Balance confidence
Time frame: Change from baseline at 8 weeks and 5 months
Core Muscle Strength
Time frame: Change from baseline at 8 weeks and 5 months
Core Muscle Endurance- Trunk Flexor
Time frame: Change from baseline at 8 weeks and 5 months
Core Muscle Endurance- Trunk Extansor
Time frame: Change from baseline at 8 weeks and 5 months
Core Muscle Endurance- Side Bridge
Time frame: Change from baseline at 8 weeks and 5 months
Perceived Mobility
Time frame: Change from baseline at 8 weeks and 5 months
Joint Position Sense-Knee
Time frame: Change from baseline at 8 weeks and 5 months
Joint Position Sense-Trunk
Time frame: Change from baseline at 8 weeks and 5 months
pelvic parameter of gait
Time frame: Change from baseline at 8 weeks and 5 months
Step symmetry
Time frame: Change from baseline at 8 weeks and 5 months
Stance symmetry
Time frame: Change from baseline at 8 weeks and 5 months
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 27 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal stabilization training through telerehabilitation and Spinal stabilization training face-to-face in people with Amputation, run by Ankara Yildirim Beyazıt 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 4 inclusion and 4 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 27 Dec 2024. 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?
gait speed (time frame: Change from baseline at 8 weeks and 5 months). 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 27 Dec 2024.