- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07633249
Effect of Core Stability Training on Trunk Control and Sitting Balance in Patients With Paraplegia
Effect of Core Stability Training on Trunk Control and Sitting Balance in Patients With Paraplegia: A Randomized Controlled Trial
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
This randomized controlled trial was conducted to evaluate the effectiveness of core stability training in improving trunk control and sitting balance in patients with paraplegia due to traumatic incomplete spinal cord injury. Forty-six participants diagnosed with incomplete SCI at neurological levels T6-T12 were randomly assigned into two groups. The study group received core stability training in addition to selected conventional physical therapy, while the control group received the same selected physical therapy program only.
Outcome measures included trunk control assessed by the Trunk Impairment Scale (TIS), sitting balance assessed by the Seated Functional Reach Test (SFRT) and T-shirt Test, and weight-bearing symmetry assessed using the Wii Balance Board (WBB). The study aimed to determine whether adding core stability training could significantly improve trunk control, sitting balance, and weight distribution symmetry in this population.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Giza Governorate
-
Giza, Giza Governorate, Egitto, 12613
- Faculty of physical therapy Cairo University
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Patients with traumatic incomplete SCI.
- Neurological level between T6 and T12 according to ASIA classification.
- Age from 25 to 35 years.
- Ability to maintain unsupported sitting.
- Medically stable condition.
- Adequate cognitive ability to follow instructions.
- Duration of injury more than six months.
- Moderate trunk impairment (TIS score 8-14).
- BMI less than 30 kg/m
Exclusion Criteria:
- other neurological disorders affecting balance.
- Uncontrolled cardiovascular conditions.
- Active lumbar or pelvic pressure sores.
- Orthopedic disorders affecting trunk control or sitting balance.
- Severe spasticity interfering with sitting balance
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Control Group
Participants received selected conventional physical therapy program.
|
Patients received selected conventional physical therapy program in form of:
Treatment was conducted for about 60 minutes, three sessions per week for eight weeks |
|
Sperimentale: Study Group
Participants received the same selected conventional physical therapy program in addition to Core Stability Training.
|
Patients received selected conventional physical therapy program in form of:
Treatment was conducted for about 60 minutes, three sessions per week for eight weeks The core stability program consisted of progressive trunk stabilization exercises targeting deep trunk muscles. Training included:
The sessions were divided into 40-45 minutes of selected conventional physical therapy modalities and exercises, followed immediately by 15-20 minutes of progressive Core Stability Training (CST) targeting the deep stabilizing muscles of the trunk . |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Weight Distribution Symmetry (Wii Balance Board)
Lasso di tempo: Baseline and after 8 weeks
|
Assessment of sitting weight-bearing symmetry using the Wii Balance Board by measuring the percentage of body weight distributed between the right and left sides.
|
Baseline and after 8 weeks
|
|
Trunk Impairment Scale (TIS)
Lasso di tempo: Baseline and after 8 weeks
|
Assessment of trunk control through evaluation of static sitting balance, dynamic sitting balance, and trunk coordination.
Higher scores indicate better trunk performance.
|
Baseline and after 8 weeks
|
|
Seated Functional Reach Test (SFRT)
Lasso di tempo: Baseline and after 8 weeks
|
Assessment of dynamic sitting balance by measuring maximum forward reaching distance while maintaining sitting stability.
|
Baseline and after 8 weeks
|
|
T-shirt Test
Lasso di tempo: Baseline and after 8 weeks
|
Functional assessment of dynamic sitting balance and trunk coordination through timed dressing performance while seated.
|
Baseline and after 8 weeks
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Mohamed A Fathy, BSc, Cairo University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- P.T.REC\012\006398)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su selected conventional physical therapy program
-
Dr. Mohammad Auais, PhDReclutamentoFratture dell'ancaCanada