Joint InstabilityNCT02115971
Jumping Exercises Approach in Individuals With Chronic Ankle Instability
A study testing Jumping exercise and Strength exercise in people with Joint Instability and Chronic Disease, run by Swanenburg at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Joint Instability, Chronic Disease, Sprains
- What is being tested?
- Jumping exercise and Strength exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2013to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ankle injury more than 6 months ago
- Chronic instability
- Functional instability of the ankle
- Experience with proprioceptive exercises
Who cannot join
- 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
Show all 9Show fewer
- Diseases that affect the balance
- Serious diseases such as tumors, infections, neuropathies, severe articular degeneration
- Non-German-speaking patients
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Balgrist Univeresty Hospital
Zurich, Canton of Zurich, 8008
About this study
Official title: 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.
Read the 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).
- Conditions
- Joint Instability, Chronic Disease, Sprains
- Being tested
- Jumping exercise, Strength exercise
- Keywords
- chronic, functional, instability, ankle
- Medical subject headings
- Joint Instability, Chronic Disease, Sprains and Strains, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jumping exerciseOther
Total 120min exercise
Strength exerciseOther
Total 120 min exercise
| Study group | Role | What they receive |
|---|---|---|
| Jumping exercise | Experimental | 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. Receives: Other: Jumping exercise |
| Strength exercise | Active comparator | 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. Receives: Other: Strength exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from Baseline in Gait variables at week 3, week 7, and at the end of therapy (week 12)
Secondary outcomes (4)
Balance
Time to Stability (Forceplate Accusway AMTI)
- 1 leg jump test
- step down test
Measured: 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.
Measured: 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.
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startSep 2013
- Primary completionAug 2015
- Study completionAug 2015
Why it stopped: The recruitment process could not provide us with enough participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swanenburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Swanenburg, Balgrist University Hospital
- Investigators
- Jaap Swanneburg, PhD, Principal investigator, Balgrist Univeresty Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115971
- Sponsor's protocol ID
- Balgrist 2009-124
- Other IDs
- KEK-ZH-Nr. 2009-124
- Status last verified
- Jul 2016
- First submitted
- 3 Apr 2014
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a 12-week Training Jumping Exercises Program in Individuals With Chronic Ankle Instability: Randomized Controlled Trial Pilot Study
- ClinicalTrials.gov ID
- NCT02115971
- Acronym / sponsor ID
- Balgrist 2009-124
- Conditions
- Joint Instability, Chronic Disease, Sprains
- Keywords
- chronic, functional, instability, ankle
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The recruitment process could not provide us with enough participants
- Enrolment
- 10 participants (actual)
- Lead sponsor
- SwanenburgUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 16 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jumping exercise | Experimental | Other: Jumping exercisePhysical 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. |
| Strength exercise | Active comparator | Other: Strength exercisePhysical 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ankle injury more than 6 months ago
- Chronic instability
- Functional instability of the ankle
- Experience with proprioceptive exercises
Key exclusion criteria (9 listed)
- Foot surgery
- Fresh ankle injury
- Acute foot pain with signs of inflammation
- Mechanical / anatomical ankle instability
- Athletes with regularly jumping exercise (eg volleyball, basketball)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jumping exerciseTotal 120min exercise | Other | Jumping exercise |
| Strength exerciseTotal 120 min exercise | Other | Strength exercise |
Primary outcome
Change from Baseline in Gait variables
Time frame: 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
4 secondary outcomes
Balance
Time frame: Baseline, week 3, week 7, and at the end of therapy (week 12)
Health questionnaire
Time frame: Baseline, week 3, week 7, and at the end of therapy (week 12), followup 12 months
Foot function questionnaire
Time frame: Baseline, week 3, week 7, and at the end of therapy (week 12)
Personal calendar
Time frame: 12 months
Results and safety
The study was stopped early (reason given: The recruitment process could not provide us with enough participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
Related trials for Joint Instability
Active, not recruiting
ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population
Primary Knee Arthroplasty
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruitingObservational study
Evaluation of Medium Cross-linked Polyethylene With and Without Vitamin E for Total Knee Arthroplasty
Osteoarthritis, Knee, Arthritis, Rheumatoid
RecruitingObservational study
A Study on Associations Between Multidimensional Human Phenotypic Traits and Human Growth and Development
Musculoskeletal Growth and Development
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaap Swanneburg, PhD principal investigator
Balgrist Univeresty Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jumping exercise and Strength exercise in people with Joint Instability and Chronic Disease, run by Swanenburg at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The recruitment process could not provide us with enough participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Gait variables (time frame: Change from Baseline in Gait variables at week 3, week 7, and at the end of therapy (week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2016.