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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Disease; Joint Instability; Sprains
• Intervention / Treatment: Other: Jumping exercise; Other: Strength exercise

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8008
      • Balgrist Univeresty Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Jumping exercise; Total 120min exercise
Active Comparator: 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.	Other: Strength exercise; Total 120 min exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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)
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

Collaborators and Investigators

• Sponsor: Swanenburg
• Investigators: Principal Investigator: Jaap Swanneburg, PhD, Balgrist Univeresty Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: April 3, 2014
• First Submitted That Met QC Criteria: April 15, 2014
• First Posted (Estimate): April 16, 2014

Study Record Updates

• Last Update Posted (Estimate): July 20, 2016
• Last Update Submitted That Met QC Criteria: July 19, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: chronic; functional; instability; ankle
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Joint Diseases; Musculoskeletal Diseases; Chronic Disease; Joint Instability
• Other Study ID Numbers: Balgrist 2009-124; KEK-ZH-Nr. 2009-124 (Other Identifier: Ethics commission of the Canton Zurich, Switzerland)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No