- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02115971
Jumping Exercises Approach in Individuals With Chronic Ankle Instability
The Effect of a 12-week Training Jumping Exercises Program in Individuals With Chronic Ankle Instability: Randomized Controlled Trial Pilot Study
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
There is a need for;
- more homogeneous sub- groups with chronic functional instability of the ankle.
- Studies are needed that older patients (up to 50 years) and also take into account women.
- In addition, studies should be performed in a clinical environment and also at the same time clinically adapted test can be used as a form measurement.
( Hiller et al. , 2011).
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
ZH
-
Zurich, ZH, Švýcarsko, 8008
- Balgrist Univeresty Hospital
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Ankle injury more than 6 months ago
- Chronic instability
- Functional instability of the ankle
- Experience with proprioceptive exercises
Exclusion Criteria:
- Foot surgery
- Fresh ankle injury
- Acute foot pain with signs of inflammation
- Mechanical / anatomical ankle instability
- Athletes with regularly jumping exercise (eg volleyball, basketball)
- Taking medications which affect balance and coordination
- Diseases that affect the balance
- Serious diseases such as tumors, infections, neuropathies, severe articular degeneration
- Non-German-speaking patients
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Jumping exercise
Physical therapy with a focus on specific jumping exercise. The jumping exercise will be performed for 12 weeks (3x/week), with a break of day between workouts. The 40-minute workout is completed 2 times under supervision in the clinic's internal training group for outpatients. 1 time they train on their own at home, based on a defined training program. The training process is documented by the training protocol. The incipient exercise intensity is taking personal performance into account. The exercise intensity is increased by a progressive scheme. |
Total 120min exercise
|
|
Aktivní komparátor: Strength exercise
Physical Therapy with a focus on stability and strength exercise. Strength exercise arm has also same duration of 12 weeks with comparable intensity. The program is according to a predetermined program. The 60-minute training is completed twice under supervision in the clinic's internal training group for outpatients.There is no contact with participants of other group. Between the two exercise sessions there is a training free day. The training process is documented by the training protocol. The incipient exercise intensity is considering personal performance. The intensity is increased after workout usual principles. The exercises are described with clear image and load parameters. The training exercises are regularly monitored. |
Total 120 min exercise
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change from Baseline in Gait variables
Časové okno: Change from Baseline in Gait variables at week 3, week 7, and at the end of therapy (week 12)
|
Gait variables will be assessed with the OptoGait system OptoGait system is a floor-based photocell system for measuring spatiotemporal gait parameters. All measurements will be executed within 1hour |
Change from Baseline in Gait variables at week 3, week 7, and at the end of therapy (week 12)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Balance
Časové okno: Baseline, week 3, week 7, and at the end of therapy (week 12)
|
Time to Stability (Forceplate Accusway AMTI)
|
Baseline, week 3, week 7, and at the end of therapy (week 12)
|
|
Health questionnaire
Časové okno: Baseline, week 3, week 7, and at the end of therapy (week 12), followup 12 months
|
EQ-5D is a standardised instrument for use as a measure of health outcome.
|
Baseline, week 3, week 7, and at the end of therapy (week 12), followup 12 months
|
|
Foot function questionnaire
Časové okno: Baseline, week 3, week 7, and at the end of therapy (week 12)
|
The Foot and Ankle Ability Measure (FAAM) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments.
|
Baseline, week 3, week 7, and at the end of therapy (week 12)
|
|
Personal calendar
Časové okno: 12 months
|
Participant could enter any new ankle sprain into this calendar.
As soon as possible after new ankle sprain the participant had to fill in the date, its cause, and sprain-related injuries.
The calendar pages contained questions about the circumstances surrounding the new ankle sprain, including how and where it happened, activity performed, possible injury symptoms, time to recover and whether medical assistance or physical therapy was needed.
Participants are also requested to record direct medical costs (e.g.
physiotherapy, visits to general practitioners and medical specialists, nursing care, and medication) and indirect cost (e.g.
disability related loss) using the "personal calendar".
At the end of 2 month, a calendar page was sent by each patient to the investigators
|
12 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Jaap Swanneburg, PhD, Balgrist Univeresty Hospital
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Balgrist 2009-124
- KEK-ZH-Nr. 2009-124 (Jiný identifikátor: Ethics commission of the Canton Zurich, Switzerland)
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .