AmputationNCT06556082
Effect of PNF-Based Upper Extremity Strengthening With Core Stabilization on Fitness in Amputee Football Players
A study testing Training in people with Amputation and Lower Limb Amputation, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
Amputee football (AF) is a disability-specific football in which amputees can participate. This study aims to determine the effect of PNF-based upper extremity strengthening exercises combined with core stabilization exercises on physical fitness parameters in amputee football players. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Amputation, Lower Limb Amputation
- What is being tested?
- Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- At least one year of experience in playing amputee soccer.
- Transtibial, knee disarticulation, or transfemoral level amputation.
Who cannot join
- Presence of upper extremity amputation.
- Bilateral lower extremity amputation.
- Underwent upper or lower extremity surgery within the last 6 months.
- Neurological disease, vestibular or visual problems.
- Use of medication affecting the central nervous system.
- Any pathology that may affect motor performance.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Uskudar University Physiotherapy and Rehabilitation Application and Research Center
Istanbul
About this study
Official title: The Effect of Proprioceptive Neuromuscular Facilitation Based Upper Extremity Strengthening Exercises Combined With Core Stabilization Training on Physical Fitness Parameters in Amputee Football Players
Amputee football (AF) is a disability-specific football in which amputees can participate. This study aims to determine the effect of PNF-based upper extremity strengthening exercises combined with core stabilization exercises on physical fitness parameters in amputee football players. In the study, amputee soccer players will be randomly divided into two groups training and control groups. In addition to the standard training programs in the off-season, the amputee athletes in the training group will receive PNF-based upper extremity strengthening training combined with core stabilization training by the same physiotherapist 3 days a week for 8 weeks. The amputee football players in the control group will be given upper extremity strengthening training with free weights in addition to core stabilization training 3 days a week for 8 weeks. The physical and demographic characteristics of the cases who signed the consent form will be recorded. Initial evaluations will be made before the start of the exercise training program and secondary evaluations will be made at the end of 8 weeks. Detailed information about the participants will be obtained with the Descriptive Characteristics Information Form. Single Leg Balance Test, Berg Balance Scale and Activity Specific Balance Confidence Scale will be used to obtain information about postural control and balance strategies of the participants. Pressure Feedback Unit will be used to measure the stabilization capacity of deep spinal muscles. Trunk muscle endurance tests developed by McGill will be used to assess the level of core stability. Isokinetic muscle strength of the upper extremity muscles will be measured with the ISOMED 2000 (2017-Germany) device. Hand grip strength will be measured with Jamar Hand Dynanometer. Closed Kinetic Ring Upper Extremity Test will be used to measure the strength, anaerobic power, and closed kinetic chain stability of the upper extremity. The Distance Triple Hop Test will be used to assess the strength, speed, balance, and control ability of a lower extremity with special emphasis on the distance traveled by the lower extremity. Sprint Test will be used to measure the running performance of amputee soccer players. The data will then be analyzed and interpreted with appropriate statistical methods.
Read the detailed description
Amputee football (AF) is a disability-specific football in which amputees can participate. Optimum flexibility, strength, endurance, speed, and agility are required to perform adequately in amputee football. However, amputee soccer requires intense strength and stability requirements on the upper extremities and trunk, especially due to the use of crutches. The aim of this study is to determine the effect of PNF-based upper extremity strengthening exercises combined with core stabilization exercises on physical fitness parameters in amputee football players. In the study, amputee soccer players will be randomly divided into two groups training and control groups. In addition to the standard training programs in the off-season, the amputee athletes in the training group will receive PNF-based upper extremity strengthening training combined with core stabilization training by the same physiotherapist 3 days a week for 8 weeks. The amputee football players in the control group will be given upper extremity strengthening training with free weights in addition to core stabilization training 3 days a week for 8 weeks. The physical and demographic characteristics of the cases who signed the consent form will be recorded. Initial evaluations will be made before the start of the exercise training program and secondary evaluations will be made at the end of 8 weeks. Detailed information about the participants will be obtained with the Descriptive Characteristics Information Form. Single Leg Balance Test, Berg Balance Scale, and Activity Specific Balance Confidence Scale will be used to obtain information about postural control and balance strategies of the participants. Pressure Feedback Unit will be used to measure the stabilization capacity of deep spinal muscles. Trunk muscle endurance tests developed by McGill will be used to assess the level of core stability. Isokinetic muscle strength of the upper extremity muscles will be measured with the ISOMED 2000 (2017-Germany) device. Hand grip strength will be measured with Jamar Hand Dynanometer. Closed Kinetic Ring Upper Extremity Test will be used to measure the strength, anaerobic power, and closed kinetic chain stability of the upper extremity. The Distance Triple Hop Test will be used to assess the strength, speed, balance, and control ability of a lower extremity with special emphasis on the distance traveled by the lower extremity. Sprint Test will be used to measure the running performance of amputee soccer players. The data will then be analyzed and interpreted with appropriate statistical methods.
- Conditions
- Amputation, Lower Limb Amputation
- Being tested
- Training, Control Group
- Keywords
- Amputee Football, Physical Fitness, Balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingOther
Proprioceptive Neuromuscular Facilitation(PNF) based upper extremity strengthening exercises to increase upper extremity muscle strength will be applied to the participants in the training group 3 days a week for 8 weeks. PNF-based upper extremity strengthening exercises will be performed with an elastic resistive band using bilateral symmetrical PNF patterns of "Flexion-Adduction-External Rotation-Extension-Abduction-Internal Rotation", "Flexion-Abduction-External Rotation-Extension-Adduction-Internal Rotation" on two different diagonals while individuals are in a sitting position in a supported chair. Core Stabilization Training will be continued for 8 weeks by increasing the difficulty and intensity of the exercises with limb movements and floor modifications after the amputee football players are taught how to find their neutral spine and how to maintain the position.
Control GroupOther
The control group will be trained with isotonic strengthening exercises of upper extremity muscles with free weights and core stabilization training 3 days a week for 8 weeks. Isotonic exercises involve muscle contraction with movement, where the muscle length changes while maintaining constant tension. Free weights such as dumbells will be used in the implementation of the exercises. 1 Repetition Maximum (1RM) method will be used to determine the progression of the exercises.
| Study group | Role | What they receive |
|---|---|---|
| Training Group | Experimental | In addition to the standard training programs in the off-season period; PNF-based upper extremity strengthening training will be performed 3 days a week for 8 weeks in addition to core stabilization training. Receives: Other: Training |
| Control Group | Experimental | The amputee football players in the control group will be trained 3 days a week for 8 weeks with isotonic strengthening exercises of the upper extremity muscles with free weights and core stabilization training. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic Upper Extremity Muscle Strength
The strength of the shoulder, elbow, and wrist muscles will be assessed using an isokinetic dynamometer (ISOMED 2000). Measurements will be taken at angular velocities of 60°/s and 180°/s in concentric-concentric mode for abduction-adduction and internal-external rotation movements. The peak torque values will be recorded.
Measured: Baseline (pre-intervention) and at 8 weeks (post-intervention).
Core Muscle Strength
Core muscle strength will be measured using the Stabilizer Pressure Biofeedback Unit (Chattanoga Group,2005). The device will be used to assess the ability of participants to maintain a neutral spine position during various core stabilization exercises.
Measured: Baseline (pre-intervention) and at 8 weeks (post-intervention).
Sprint Performance
Sprint performance will be assessed by recording the time it takes for participants to complete 10m, 20m, and 30m sprints using crutches. Two trials will be conducted, and the best times will be recorded.
Measured: Baseline (pre-intervention) and at 8 weeks (post-intervention).
Secondary outcomes (7)
Postural Stability
The Berg Balance Scale will be used to assess the overall postural stability and balance of the participants. This test consists of 14 tasks that measure a range of balance activities, each scored from 0 to 4. Higher scores indicate better balance and stability.
Measured: Baseline (pre-intervention) and at 8 weeks (post-intervention).
Balance Confidence
Activities-Specific Balance Confidence Scale (ABC) will assess the participants' confidence in maintaining balance during various activities. It includes 16 items scored from 0% (no confidence) to 100% (full confidence).
Measured: Baseline (pre-intervention) and at 8 weeks (post-intervention).
Static Balance Assessment
The Single Leg Stance Test will be used to assess static balance and postural control. Participants will be asked to stand on one leg with their arms either on their hips or crossed over their shoulders. The time (in seconds) they can maintain balance without losing posture will be recorded. The best of three trials will be used for analysis.
Measured: Baseline (pre-intervention) and at 8 weeks (post-intervention).
Upper Extremity Endurance and Stability
Closed Kinetic Chain Upper Extremity Stability Test will be used to assess upper extremity stability and endurance. Participants will perform in push-up position, touching two lines placed 0.9 meters apart as many times as possible within 15 seconds. The total number of touches will be recorded.
Measured: Baseline (pre-intervention) and at 8 weeks (post-intervention).
Grip Strength Assessment
Grip strength will be measured using a Jamar hand dynamometer according to the American Society of Hand Therapists (ASHT) protocol. Participants will perform three trials with their dominant hand, and the average value will be recorded.
Measured: Baseline (pre-intervention) and at 8 weeks (post-intervention).
Athletic Performance (Triple Hop Distance Test)
The Triple Hop Distance Test will be used to assess the explosive power, balance, and control of the lower extremity. Participants will be asked to hop as far as possible on one leg, three consecutive times without losing balance. The distance from the starting point to the final landing point will be measured and recorded.
Measured: Baseline (pre-intervention) and at 8 weeks (post-intervention).
Core Stability Level
Core stability will be evaluated using the McGill core tests, which include the Sorensen test, trunk flexion test, and side bridge tests. These tests measure the endurance of the core muscles by recording the time (in seconds) participants can maintain specific postures.
Measured: Baseline (pre-intervention) and at 8 weeks (post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start1 Sep 2024
- Primary completion1 Jun 2025
- Study completion1 Jul 2026 (estimated)
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.
- 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
- Model description
- Training and Control Group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mert İlhan, Uskudar University
- Investigators
- Fatih Erbahçeci, PhD., Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556082
- Sponsor's protocol ID
- 2024-RCTILHAN-01
- Status last verified
- Mar 2026
- First submitted
- 13 Aug 2024
- Last updated
- 1 Apr 2026
- 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 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Proprioceptive Neuromuscular Facilitation Based Upper Extremity Strengthening Exercises Combined With Core Stabilization Training on Physical Fitness Parameters in Amputee Football Players
- ClinicalTrials.gov ID
- NCT06556082
- Acronym / sponsor ID
- 2024-RCTILHAN-01
- Conditions
- Amputation, Lower Limb Amputation
- Keywords
- Amputee Football, Physical Fitness, Balance
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 15 Aug 2024 (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.
Amputee football (AF) is a disability-specific football in which amputees can participate. This study aims to determine the effect of PNF-based upper extremity strengthening exercises combined with core stabilization exercises on physical fitness parameters in amputee football players. In the study, amputee soccer players will be randomly divided into two groups training and control groups. In addition to the standard training programs in the off-season, the amputee athletes in the training group will receive PNF-based upper extremity strengthening training combined with core stabilization training by the same physiotherapist 3 days a week for 8 weeks. The amputee football players in the control group will be given upper extremity strengthening training with free weights in addition to core stabilization training 3 days a week for 8 weeks. The physical and demographic characteristics of the cases who signed the consent form will be recorded. Initial evaluations will be made before the start of the exercise training program and secondary evaluations will be made at the end of 8 weeks. Detailed information about the participants will be obtained with the Descriptive Characteristics Information Form. Single Leg Balance Test, Berg Balance Scale and Activity Specific Balance Confidence Scale will be used to obtain information about postural control and balance strategies of the participants. Pressure Feedback Unit will be used to measure the stabilization capacity of deep spinal muscles. Trunk muscle endurance tests developed by McGill will be used to assess the level of core stability. Isokinetic muscle strength of the upper extremity muscles will be measured with the ISOMED 2000 (2017-Germany) device. Hand grip strength will be measured with Jamar Hand Dynanometer. Closed Kinetic Ring Upper Extremity Test will be used to measure the strength, anaerobic power, and closed kinetic chain stability of the upper extremity. The Distance Triple Hop Test will be used to assess the strength, speed, balance, and control ability of a lower extremity with special emphasis on the distance traveled by the lower extremity. Sprint Test will be used to measure the running performance of amputee soccer players. The data will then be analyzed and interpreted with appropriate statistical methods.
Detailed description
Amputee football (AF) is a disability-specific football in which amputees can participate. Optimum flexibility, strength, endurance, speed, and agility are required to perform adequately in amputee football. However, amputee soccer requires intense strength and stability requirements on the upper extremities and trunk, especially due to the use of crutches. The aim of this study is to determine the effect of PNF-based upper extremity strengthening exercises combined with core stabilization exercises on physical fitness parameters in amputee football players. In the study, amputee soccer players will be randomly divided into two groups training and control groups. In addition to the standard training programs in the off-season, the amputee athletes in the training group will receive PNF-based upper extremity strengthening training combined with core stabilization training by the same physiotherapist 3 days a week for 8 weeks. The amputee football players in the control group will be given upper extremity strengthening training with free weights in addition to core stabilization training 3 days a week for 8 weeks. The physical and demographic characteristics of the cases who signed the consent form will be recorded. Initial evaluations will be made before the start of the exercise training program and secondary evaluations will be made at the end of 8 weeks. Detailed information about the participants will be obtained with the Descriptive Characteristics Information Form. Single Leg Balance Test, Berg Balance Scale, and Activity Specific Balance Confidence Scale will be used to obtain information about postural control and balance strategies of the participants. Pressure Feedback Unit will be used to measure the stabilization capacity of deep spinal muscles. Trunk muscle endurance tests developed by McGill will be used to assess the level of core stability. Isokinetic muscle strength of the upper extremity muscles will be measured with the ISOMED 2000 (2017-Germany) device. Hand grip strength will be measured with Jamar Hand Dynanometer. Closed Kinetic Ring Upper Extremity Test will be used to measure the strength, anaerobic power, and closed kinetic chain stability of the upper extremity. The Distance Triple Hop Test will be used to assess the strength, speed, balance, and control ability of a lower extremity with special emphasis on the distance traveled by the lower extremity. Sprint Test will be used to measure the running performance of amputee soccer players. The data will then be analyzed and interpreted with appropriate statistical methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Training and Control Group
| Arm | Type | Receives |
|---|---|---|
| Training Group | Experimental | Other: TrainingIn addition to the standard training programs in the off-season period; PNF-based upper extremity strengthening training will be performed 3 days a week for 8 weeks in addition to core stabilization training. |
| Control Group | Experimental | Other: Control GroupThe amputee football players in the control group will be trained 3 days a week for 8 weeks with isotonic strengthening exercises of the upper extremity muscles with free weights and core stabilization training. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- At least one year of experience in playing amputee soccer.
- Transtibial, knee disarticulation, or transfemoral level amputation.
Key exclusion criteria (6 listed)
- Presence of upper extremity amputation.
- Bilateral lower extremity amputation.
- Underwent upper or lower extremity surgery within the last 6 months.
- Neurological disease, vestibular or visual problems.
- Use of medication affecting the central nervous system.
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 |
|---|---|---|
| TrainingProprioceptive Neuromuscular Facilitation(PNF) based upper extremity strengthening exercises to increase upper extremity muscle strength will be applied to the participants in the training group 3 days a week for 8 weeks. PNF-based upper extremity strengthening exercises will be performed with an elastic resistive band using bilateral symmetrical PNF patterns of "Flexion-Adduction-External Rotation-Extension-Abduction-Internal Rotation", "Flexion-Abduction-External Rotation-Extension-Adduction-Internal Rotation" on two different diagonals while individuals are in a sitting position in a supported chair. Core Stabilization Training will be continued for 8 weeks by increasing the difficulty and intensity of the exercises with limb movements and floor modifications after the amputee football players are taught how to find their neutral spine and how to maintain the position. | Other | Training Group |
| Control GroupThe control group will be trained with isotonic strengthening exercises of upper extremity muscles with free weights and core stabilization training 3 days a week for 8 weeks. Isotonic exercises involve muscle contraction with movement, where the muscle length changes while maintaining constant tension. Free weights such as dumbells will be used in the implementation of the exercises. 1 Repetition Maximum (1RM) method will be used to determine the progression of the exercises. | Other | Control Group |
Primary outcome
Isokinetic Upper Extremity Muscle Strength
Time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention).
The strength of the shoulder, elbow, and wrist muscles will be assessed using an isokinetic dynamometer (ISOMED 2000). Measurements will be taken at angular velocities of 60°/s and 180°/s in concentric-concentric mode for abduction-adduction and internal-external rotation movements. The peak torque values will be recorded.
Core Muscle Strength
Time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention).
Core muscle strength will be measured using the Stabilizer Pressure Biofeedback Unit (Chattanoga Group,2005). The device will be used to assess the ability of participants to maintain a neutral spine position during various core stabilization exercises.
Sprint Performance
Time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention).
Sprint performance will be assessed by recording the time it takes for participants to complete 10m, 20m, and 30m sprints using crutches. Two trials will be conducted, and the best times will be recorded.
7 secondary outcomes
Postural Stability
Time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention).
Balance Confidence
Time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention).
Static Balance Assessment
Time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention).
Upper Extremity Endurance and Stability
Time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention).
Grip Strength Assessment
Time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention).
Athletic Performance (Triple Hop Distance Test)
Time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention).
Core Stability Level
Time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- 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 Erbahçeci, PhD. study director
Hacettepe 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 Training in people with Amputation and Lower Limb Amputation, run by Uskudar 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 2 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Isokinetic Upper Extremity Muscle Strength (time frame: Baseline (pre-intervention) and at 8 weeks (post-intervention).). The study lists 3 primary outcomes in all. 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 1 Apr 2026.