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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02115971
Other study ID # Balgrist 2009-124
Secondary ID KEK-ZH-Nr. 2009-
Status Terminated
Phase N/A
First received April 3, 2014
Last updated July 19, 2016
Start date September 2013
Est. completion date August 2015

Study information

Verified date July 2016
Source Balgrist University Hospital
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical Trial Summary

The aim of this pilot study is to analyze the effect of a 12-week specific jump training compared with conventional therapy in patients with chronic functional instability of the ankle. It is to be evaluated to what extent the symptoms in of chronic functional instability of the ankle can be influenced in everyday life.


Description:

There is a need for;

1. more homogeneous sub- groups with chronic functional instability of the ankle.

2. Studies are needed that older patients (up to 50 years) and also take into account women.

3. 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).


Recruitment information / eligibility

Status Terminated
Enrollment 10
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Jumping exercise
Total 120min exercise
Strength exercise
Total 120 min exercise

Locations

Country Name City State
Switzerland Balgrist Univeresty Hospital Zurich ZH

Sponsors (1)

Lead Sponsor Collaborator
Swanenburg

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline in Gait variables 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) No
Secondary Balance Time to Stability (Forceplate Accusway AMTI)
1 leg jump test
step down test
Baseline, week 3, week 7, and at the end of therapy (week 12) No
Secondary Health questionnaire 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 No
Secondary Foot function questionnaire 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) No
Secondary Personal calendar 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 No
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