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Healthy VolunteersNCT02218086

Effectivity of Slackline-Training in Physiotherapy

A study testing Slackline, Wobbling Board and Pre-training in people with Healthy Volunteers and Persons With no Known Significant Health Problems, run by THIM - die internationale Hochschule für Physiotherapie at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Slacklines have been established in the last few years as a training equipment in sports such as climbing, skiing and others to increase postural control. Furthermore, slacklines are used in physiotherapy in terms of stabilizing training such as wobbling boards. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
What is being tested?
Slackline, Wobbling Board and Pre-training
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSwitzerland
Study dates
1 Aug 2014to 31 May 2020
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 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • young healthy, 18-30 years old
  • small operations on muscle-skeletal-system on upper extremities
  • birth control pill

Who cannot join

  • any actual injuries on lower extremities
  • injuries on lower extremities less than one year back
  • operations of muscle-skeletal-system at shoulder/neck, trunk/pelvis and lower extremities
  • fear of falling
  • any medications
  • cardiac pacemaker or cardiac arrhythmia
Show all 9Show fewer
  • pregnancy
  • skeletal anomaly
  • appendicitis less then 2 years back

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Thim van der Laan University College Physiotherapy

    Landquart, Kanton Graubünden, 7302

Other trials in Switzerland

About this study

Official title: Effectivity of Slackline-Training in Physiotherapy - a Randomised Controlled Study

Slacklines have been established in the last few years as a training equipment in sports such as climbing, skiing and others to increase postural control. Furthermore, slacklines are used in physiotherapy in terms of stabilizing training such as wobbling boards.

However, if slackline training is effective in rehabilitation has not been investigated yet. Therefore, to goal of this study will be to investigate the effectivity of slackline training in physiotherapy compared to a wobbling board with a single tilting axis.

Outcomes will be electromyographic-data and the kinetics of the whole body.

Read the detailed description

Comparing beginners pre-training (less than 1 hour of slackline training) to post-training (9 times 30 minutes of individual, controlled training) to investigate the effects of balance training on a slackline.

Comparing beginners (less than 1 hour of slackline training) to professionals (more than 100 hours of slackline training) to investigate differences in balance strategies.

Comparing professionals during slacklining under two different conditions of their visual anchor: fix vs. moving. This to investigate the role of the visual system during balance reactions.

Comparing slackline training versus a demanding training standing-on-1-leg. We do compare Y-balance-performance, performance on the MFT challenge disc, each compared with simultanousely recording body Sway (lower trunk) with SwayStar.

Muscle activity will be investigated by absolute amplitude (mV) and frequency to get an idea of which muscle fibers are acting during the task and how the activation pattern may change through motor learning.

Body kinematics should show movement strategies especially differences in roll and pitch control of the body.

Being tested
Slackline, Wobbling Board, Pre-training, Fix visual anchor, Moving visual anchor
Keywords
postural control, postural balance, slackline

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SlacklineDevice

    Also called brand name: Slackbase PRO, http://medi-lines.com/slackbasepro/

    Slackbase PRO CE: certificated by european law for medical devices (EG Richtlinie 93/42/EWG)

  • Wobbling BoardDevice

    Also called name: Standbrett, serial number: 2.1.1, http://www.originell.net/index.php?_disp=40

    Wobbling Board CE: certificated by european law for medical devices (EG Richtlinie 93/42/EWG)

  • Pre-trainingDevice

    First investigation of the beginners with less than 1 hour experience with slacklining.

  • Fix visual anchorDevice

    Professionals have to gaze at a fixed visual anchor during the slacklining.

  • Moving visual anchorDevice

    Professionals have to gaze at a moving visual anchor during the slacklining.

  • Post-trainingDevice

    Second investigation of the beginners occurs after a training session of 9 times 30 minutes within a few weeks.

  • Slackline vs. standing-on-1-leg vs. controlDevice

    beginners have to train 9 times ~15minutes within y few weeks.

Study groups in NCT02218086
Study groupRoleWhat they receive
professionalsExperimentalbalancing on the slackline / wobbling board 3 times by 30 seconds balancing on the slackline with a fix visual anchor / moving visual anchor 3 times by 30 seconds
Receives: Device: Slackline; Device: Wobbling Board; Device: Fix visual anchor; Device: Moving visual anchor
beginnersExperimentalbalancing on the slackline / wobbling board 3 times by 30 seconds pre-training compared to post-training
Receives: Device: Slackline; Device: Wobbling Board; Device: Pre-training; Device: Post-training; Device: Slackline vs. standing-on-1-leg vs. control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Muscle activity using surface electromyography device. 1. measuring amplitude of muscle activation in mV (millivolt) 2. measuring frequency pattern of muscle activation to distinguish /detect activation of slow and fast muscle fibers

    single investigation for arms:

    1. BEGINNERS:
    2. slackline compared to wobble board
    3. PROFESIONALS:
    4. slackline compared to wobble board
    5. fix visual anchor compared to moving visual anchor double investigation: 1. BEGINNERS
    6. pre-training compared to post-training, expected training period average of 6 weeks, totally 9 trainings of 30 minutes each

    Measured: average of 6 weeks

Secondary outcomes (1)

  1. Whole body kinematics (composite outcome measure): a. calculating joint angles [deg & deg/s] b. calculating absolute and relative body part movements (such as trunk, pelvis, head): tilts & translations [mm, mm/s]

    single investigation for arms:

    BEGINNERS:

    1. slackline compared to wobble board

    PROFESIONALS:

    slackline compared to wobble board fix visual anchor compared to moving visual anchor

    double investigation: 1. BEGINNERS

    1. pre-training compared to post-training, expected training period average of 6 weeks, totally 9 trainings of 30 minutes each

    Measured: average of 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2014 (estimated)
  2. Study start1 Aug 2014
  3. Primary completion31 May 2020
  4. Study completion31 May 2020

Resources

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
Crossover
Model description
different protocol-arms: crossover for comparing slackline vs. wobble board vs. flamingo balance task parallel for slackline training vs. enhanced standing-on-1-leg training
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02218086
Sponsor's protocol ID
UCP-2014-0107
Other IDs
KEK-ZH-2014-0107, PB 2019-00009
Status last verified
May 2019
First submitted
12 Aug 2014
Last updated
8 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Pfusterschmied J, Lindinger S, Buchecker M, Stoggl T, Wagner H, Muller E. Effect of instability training equipment on lower limb kinematics and muscle activity. Sportverletz Sportschaden. 2013 Mar;27(1):28-33. doi: 10.1055/s-0032-1330725. Epub 2013 Feb 12.

    PubMed 23404457

  • Donath L, Roth R, Rueegge A, Groppa M, Zahner L, Faude O. Effects of slackline training on balance, jump performance & muscle activity in young children. Int J Sports Med. 2013 Dec;34(12):1093-8. doi: 10.1055/s-0033-1337949. Epub 2013 May 22.

    PubMed 23700328

  • Honegger F, Tielkens RJ, Allum JH. Movement strategies and sensory reweighting in tandem stance: differences between trained tightrope walkers and untrained subjects. Neuroscience. 2013 Dec 19;254:285-300. doi: 10.1016/j.neuroscience.2013.09.041. Epub 2013 Oct 1.

    PubMed 24090964

  • Kung UM, Horlings CG, Honegger F, Duysens JE, Allum JH. Control of roll and pitch motion during multi-directional balance perturbations. Exp Brain Res. 2009 Apr;194(4):631-45. doi: 10.1007/s00221-009-1743-3. Epub 2009 Mar 5.

    PubMed 19263044

  • Raffi M, Piras A, Persiani M, Squatrito S. Importance of optic flow for postural stability of male and female young adults. Eur J Appl Physiol. 2014 Jan;114(1):71-83. doi: 10.1007/s00421-013-2750-4. Epub 2013 Oct 23.

    PubMed 24150783

  • Pfusterschmied J, Stoggl T, Buchecker M, Lindinger S, Wagner H, Muller E. Effects of 4-week slackline training on lower limb joint motion and muscle activation. J Sci Med Sport. 2013 Nov;16(6):562-6. doi: 10.1016/j.jsams.2012.12.006. Epub 2013 Jan 16.

    PubMed 23333134

  • Paoletti P, Mahadevan L. Balancing on tightropes and slacklines. J R Soc Interface. 2012 Sep 7;9(74):2097-108. doi: 10.1098/rsif.2012.0077. Epub 2012 Apr 18.

    PubMed 22513724

  • Kung UM, Horlings CG, Honegger F, Allum JH. The effect of voluntary lateral trunk bending on balance recovery following multi-directional stance perturbations. Exp Brain Res. 2010 May;202(4):851-65. doi: 10.1007/s00221-010-2201-y. Epub 2010 Mar 4.

    PubMed 20204607

  • Kung UM, Horlings CG, Honegger F, Allum JH. Incorporating voluntary unilateral knee flexion into balance corrections elicited by multi-directional perturbations to stance. Neuroscience. 2009 Sep 29;163(1):466-81. doi: 10.1016/j.neuroscience.2009.06.009. Epub 2009 Jun 6.

    PubMed 19505537

  • Tabira T, Sakai K. Demyelination induced by T cell lines and clones specific for myelin basic protein in mice. Lab Invest. 1987 May;56(5):518-25.

    PubMed 2437389

Questions about this trial

What is this clinical trial studying?

A study testing Slackline, Wobbling Board and Pre-training in people with Healthy Volunteers and Persons With no Known Significant Health Problems, run by THIM - die internationale Hochschule für Physiotherapie 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 3 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: finished, as of the sponsor's last update on 8 Oct 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Muscle activity using surface electromyography device. 1. measuring amplitude of muscle activation in mV (millivolt) 2. measuring frequency pattern of muscle activation to distinguish /detect activation of slow and fast muscle fibers (time frame: average of 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02218086, which also lists 10 linked publications.

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 8 Oct 2020.

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Effectivity of Slackline-Training in Physiotherapy | AzTrials