NCT06556082

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Sep 2024Jul 2026

First Submitted

Initial submission to the registry

August 13, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 15, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

August 13, 2024

Last Update Submit

March 26, 2026

Conditions

Keywords

Amputee FootballPhysical FitnessBalance

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Baseline (pre-intervention) and at 8 weeks (post-intervention).

Secondary Outcomes (7)

  • Postural Stability

    Baseline (pre-intervention) and at 8 weeks (post-intervention).

  • Balance Confidence

    Baseline (pre-intervention) and at 8 weeks (post-intervention).

  • Static Balance Assessment

    Baseline (pre-intervention) and at 8 weeks (post-intervention).

  • Upper Extremity Endurance and Stability

    Baseline (pre-intervention) and at 8 weeks (post-intervention).

  • Grip Strength Assessment

    Baseline (pre-intervention) and at 8 weeks (post-intervention).

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Other: Control Group

Interventions

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.

Training Group

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.

Control Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • At least one year of experience in playing amputee soccer.
  • Transtibial, knee disarticulation, or transfemoral level amputation.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uskudar University Physiotherapy and Rehabilitation Application and Research Center

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Fatih Erbahçeci, PhD.

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Training and Control Group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

August 13, 2024

First Posted

August 15, 2024

Study Start

September 1, 2024

Primary Completion

June 1, 2025

Study Completion (Estimated)

July 1, 2026

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations