- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02344446
Physical Therapy Intervention for Extended Physical Symptoms After a Sports-related Concussion
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Patients will be recruited from the ongoing Randomized Clinical Trial (Walsh University HSR 14-20) that are not returned to play and/or are not asymptomatic at the completion of their involvement in this research protocol. Based on the timeframe for their participation in the aforementioned study, these athletes will be 30 - 50 days post-concussion. At their final visit for the RCT, patients with one of the following criteria will be invited to participate in this research study:
- Lack of release for Return to Play
- Continuation of physical symptoms (headache, nausea, vomiting, balance problems, dizziness, light or noise sensitivity, numbness and/or vision problems) as recorded on the Post-Concussion Symptom Scale.
Desired sample size: 15 participants.
Skilled treatment: patients will be scheduled for a physical therapy assessment. The PTs will use a prescriptive approach to the assessment of the central nervous system, the cervical spine, and the vestibular system to determine the relative involvement of each system and dysfunction contributing to the patient's physical complaints. This assessment will include the outcome measures that will be obtained pre and post-treatment (Vertigo Symptom Scale (VSS) and the Functional Gait Assessment (FGA). Once the assessment is completed, the PT will initiate treatment, with follow-up visits for PT treatment 1 - 2 times per week. They will pragmatically design an individualized and progressive treatment plan, including manual therapy (manipulation and/or mobilization), neuromotor control strategies, and vestibular rehabilitation techniques, depending on the findings at assessment and patient response. Therapists can also tailor education regarding mental and physical rest according to specific parameters provided by the treating physician. Patients may also be prescribed a home exercise program and exercise education. The precise treatment strategies will be recorded. At each PT visit, symptomatic recovery will be tracked using the PCS.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Ohio
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North Canton, Ohio, Vereinigte Staaten, 44720
- Walsh University
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
Patients will be recruited from the ongoing Randomized Clinical Trial (Walsh University HSR 14-20) that are not returned to play and/or are not asymptomatic at the completion of their involvement in this research protocol. Based on the timeframe for their participation in the aforementioned study, these athletes will be 30 - 50 days post-concussion. At their final visit for the RCT, patients with one of the following criteria will be invited to participate in this research study:
- Lack of release for Return to Play
- Continuation of physical symptoms (headache, nausea, vomiting, balance problems, dizziness, light or noise sensitivity, numbness and/or vision problems) as recorded on the Post-Concussion Symptom Scale
Exclusion Criteria:
- Any one who is not enrolled in the aforementioned RCT
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Skilled Therapy
Differential physical therapy treatment, based on assessment results, with follow-up visits for PT treatment 1 - 2 times per week until patient achieves at least 1 primary outcome.
They will pragmatically design an individualized and progressive treatment plan, including manual therapy (manipulation and/or mobilization), neuromotor control strategies, and vestibular rehabilitation techniques, depending on the findings at assessment and patient response.
Therapists can also tailor education regarding mental and physical rest according to specific parameters provided by the treating physician.
Patients may also be prescribed a home exercise program and exercise education.
The precise treatment strategies will be recorded.
|
Active physical therapy treatment
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Symptomatic Recovery
Zeitfenster: Within 6 months of enrollment
|
Using the Post-Concussion Symptom Scale, self-reported symptomatic presentation will be tracked at each visit
|
Within 6 months of enrollment
|
|
Return to Play
Zeitfenster: Within 6 months of enrollment
|
The treating physician will determine when return to play should be initiated.
|
Within 6 months of enrollment
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Jennifer C Reneker, MSPT, Walsh Unviersity
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- WalshU
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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