- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02631486
Does Early Mobilisation Improve Outcomes After Rotator Cuff Repair?
Does Early Mobilisation After Surgical Repair of Rotator Cuff Tears Improve Biomechanical and Clinical Outcomes?
Panoramica dello studio
Descrizione dettagliata
The study will be a randomised controlled trial, which means that each participant will have equal chances to be assigned to one of 2 groups.
The first group will start the rehabilitation after 3 weeks post-surgery and the second group will start after 6 weeks.
The rehabilitation stages will start with passive movements, progressing to more active stages phases until full recovery. The whole program will last about 3 months, which is in accordance to what is normally used at the Wrightington Hospital.
Each participant will have 4 assessment sessions: 1 pre-surgery, after 3 months post-surgery, after 6 months and the last after 12 months post-surgery.
The assessment sessions will consist on answering questionnaires and a clinical assessment with equipment, which measures muscle activity and joint angles during clinical tasks.
An ultrasound scan of the shoulder to assess the integrity of the rotator cuff would be carried out one year after surgery by a consultant radiologist.
These assessments are timed with the routine orthopaedic clinic assessments so that patients do not have to make extra trips to take part in the research.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Lancashire
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Wigan, Lancashire, Regno Unito, WN6 9EP
- Wrightington Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Age between 40 and 70 years old,
- Confirmed diagnosis of rotator cuff tear
- No previous shoulder surgery
- No other musculoskeletal impairment in the assessed limb or cervical and thoracic spine.
Exclusion Criteria:
- Previous shoulder surgery
- Fixation which does not allow early mobilisation
- Other musculoskeletal impairment in the assessed limb or cervical and thoracic spine,
- People with special needs who are unable to understand the instructions needed,
- Non-English or non-Portuguese speakers.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Early
The first group will use sling for comfort only. Active assisted exercises in closed chain and in safe zone are allowed in the first 4 weeks. The rehabilitation stages will start from active assisted progressing to more active stages phases until full recovery. The whole program will last about 3 months. |
Passive exercises, active exercises, strengthening, stretching
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Comparatore attivo: Conservative
The second group will use a sling for 6 weeks.
The rehabilitation stages will start with active assisted/closed chain movements with short levers, it will progress to more active stages phases until full recovery.
The whole program will last about 3 months.
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Passive exercises, active exercises, strengthening, stretching
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Change from baseline range of motion
Lasso di tempo: Pre-surgery (baseline), change from baseline range of motion at 3 months, change from baseline range of motion at 6 months, change from baseline range of motion at 1 year
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Pre-surgery (baseline), change from baseline range of motion at 3 months, change from baseline range of motion at 6 months, change from baseline range of motion at 1 year
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change from baseline muscle activity in millivolts
Lasso di tempo: Pre-surgery (baseline), change from baseline range of motion at 3 months, change from baseline range of motion at 6 months, change from baseline range of motion at 1 year
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The muscle activity will be measured using non-invasive electromyography
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Pre-surgery (baseline), change from baseline range of motion at 3 months, change from baseline range of motion at 6 months, change from baseline range of motion at 1 year
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Re-tears ratio
Lasso di tempo: 1 year
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1 year
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Jim Richards, Professor, University of Central Lancashire
Studiare le date dei record
Studia le date principali
Inizio studio
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 (Stima)
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
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- STEMH 277
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
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 .
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