- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07715578
Effect of Balance Exercises on Performance in Amputee Football Players (AF-BALANCE)
Evaluation of the Effect of Balance Exercises on the Performance of Amputee Football Players
This randomized controlled study evaluated the effects of an 8-week balance and trunk stabilization exercise program on balance and functional performance in male amputee football players. Twenty athletes aged 18 to 45 years were randomly assigned to an intervention group or a control group.
The intervention group completed trunk stabilization, proprioceptive balance, and sport-specific plyometric exercises twice weekly in addition to routine football training. The control group continued routine football training only. Balance and functional mobility were assessed before and after the 8-week period using the Berg Balance Scale, the L-Test of Functional Mobility, and the Figure-of-8 Walk Test.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Sakarya, Tyrkia (Türkiye)
- Amputee Football Training Facility
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Male amputee football players aged 18 to 45 years.
- Unilateral lower-limb amputation.
- Classification as A1 according to the amputee football classification system.
- Active participation in amputee football for at least 6 months.
- Ability and willingness to participate in the study.
- Provision of written informed consent.
Exclusion Criteria:
- Bilateral lower-limb amputation.
- Insufficient experience in using crutches or a prosthesis.
- Any acute injury or serious neurological, cardiovascular, or other medical condition that could prevent completion of the L-Test of Functional Mobility, Figure-of-8 Walk Test, or exercise program.
- An active injury or rehabilitation condition preventing participation in football training.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Ingen inngripen: Kontrollgruppe
|
|
|
Eksperimentell: Balansetreningsgruppe
|
An 8-week exercise program performed twice weekly in addition to routine football training.
The program included trunk stabilization, proprioceptive balance exercises, and sport-specific plyometric jumping and agility exercises.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in L-Test of Functional Mobility Completion Time
Tidsramme: Baseline and 8 weeks
|
Functional mobility, speed, agility, and dynamic balance were assessed using the L-Test of Functional Mobility.
Participants completed three trials, and the mean completion time was recorded in seconds.
Lower completion times indicate better functional performance.
Change was calculated by comparing the assessment performed at baseline with the assessment performed after the 8-week intervention.
|
Baseline and 8 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Figure-of-8 Walk Test Completion Time
Tidsramme: Baseline and 8 weeks
|
Dynamic balance, agility, postural control, and directional change ability were assessed using the Figure-of-8 Walk Test.
Participants completed three trials, and the mean completion time was recorded in seconds.
Lower completion times indicate better performance.
Change was assessed from baseline to the end of the 8-week intervention.
|
Baseline and 8 weeks
|
|
Change in Figure-of-8 Walk Test Step Count
Tidsramme: Baseline and 8 weeks
|
Movement efficiency during the Figure-of-8 Walk Test was assessed by recording the number of steps required to complete the test.
Participants completed three trials, and the mean step count was calculated.
A lower number of steps indicates greater movement efficiency.
Change was assessed from baseline to the end of the 8-week intervention.
|
Baseline and 8 weeks
|
|
Change in Berg Balance Scale Total Score
Tidsramme: Baseline and 8 weeks
|
Static and functional balance were assessed using the Berg Balance Scale.
The scale contains 14 items scored from 0 to 4, providing a total score ranging from 0 to 56.
Higher scores indicate better balance and lower fall risk.
Change was assessed from baseline to the end of the 8-week intervention.
|
Baseline and 8 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- NISAMAKTAY
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .