NCT02115971

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 16, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

July 20, 2016

Status Verified

July 1, 2016

Enrollment Period

1.9 years

First QC Date

April 3, 2014

Last Update Submit

July 19, 2016

Conditions

Keywords

chronicfunctionalinstabilityankle

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Balance

    Baseline, week 3, week 7, and at the end of therapy (week 12)

  • Health questionnaire

    Baseline, week 3, week 7, and at the end of therapy (week 12), followup 12 months

  • Foot function questionnaire

    Baseline, week 3, week 7, and at the end of therapy (week 12)

  • Personal calendar

    12 months

Study Arms (2)

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.

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.

Other: Strength exercise

Interventions

Total 120min exercise

Jumping exercise

Total 120 min exercise

Strength exercise

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Ankle injury more than 6 months ago
  • Chronic instability
  • Functional instability of the ankle
  • Experience with proprioceptive exercises

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balgrist Univeresty Hospital

Zurich, Canton of Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Joint InstabilityChronic DiseaseSprains and StrainsBronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and InjuriesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Officials

  • Jaap Swanneburg, PhD

    Balgrist Univeresty Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 3, 2014

First Posted

April 16, 2014

Study Start

September 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

July 20, 2016

Record last verified: 2016-07

Locations