Jumping Exercises Approach in Individuals With Chronic Ankle Instability

Chronic Disease Clinical Trial

Official title:

The Effect of a 12-week Training Jumping Exercises Program in Individuals With Chronic Ankle Instability: Randomized Controlled Trial Pilot Study

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

• Chronic Disease
• Joint Instability
• Sprains

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