Back to resultsJumping Exercises Approach in Individuals With Chronic Ankle Instability
Primary Purpose
Joint Instability, Chronic Disease, Sprains
Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Jumping exercise
Strength exercise
Sponsored by
About this trial
This is an interventional treatment trial for Joint Instability focused on measuring chronic, functional, instability, ankle
Eligibility Criteria
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
Sites / Locations
- Balgrist Univeresty Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Jumping exercise
Strength exercise
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Balance
Time to Stability (Forceplate Accusway AMTI)
1 leg jump test
step down test
Health questionnaire
EQ-5D is a standardised instrument for use as a measure of health outcome.
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02115971
Brief Title
Jumping Exercises Approach in Individuals With Chronic Ankle Instability
Official Title
The Effect of a 12-week Training Jumping Exercises Program in Individuals With Chronic Ankle Instability: Randomized Controlled Trial Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
The recruitment process could not provide us with enough participants
Study Start Date
September 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Swanenburg
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Instability, Chronic Disease, Sprains
Keywords
chronic, functional, instability, ankle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Jumping exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Strength exercise
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Jumping exercise
Intervention Description
Total 120min exercise
Intervention Type
Other
Intervention Name(s)
Strength exercise
Intervention Description
Total 120 min exercise
Primary Outcome Measure Information:
Title
Change from Baseline in Gait variables
Description
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
Time Frame
Change from Baseline in Gait variables at week 3, week 7, and at the end of therapy (week 12)
Secondary Outcome Measure Information:
Title
Balance
Description
Time to Stability (Forceplate Accusway AMTI)
1 leg jump test
step down test
Time Frame
Baseline, week 3, week 7, and at the end of therapy (week 12)
Title
Health questionnaire
Description
EQ-5D is a standardised instrument for use as a measure of health outcome.
Time Frame
Baseline, week 3, week 7, and at the end of therapy (week 12), followup 12 months
Title
Foot function questionnaire
Description
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.
Time Frame
Baseline, week 3, week 7, and at the end of therapy (week 12)
Title
Personal calendar
Description
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
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaap Swanneburg, PhD
Organizational Affiliation
Balgrist Univeresty Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Balgrist Univeresty Hospital
City
Zurich
State/Province
ZH
ZIP/Postal Code
8008
Country
Switzerland
12. IPD Sharing Statement
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Jumping Exercises Approach in Individuals With Chronic Ankle Instability
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