NCT02693756

Brief Summary

Gait stability is reduced as early as from age 40 to 50. Gait stability can be improved in patients with neurological diseases or in healthy elderly persons with exercises. There is evidence that mental practice, also called motor imagery, the imagination of performing a movement, can also improve an activity or balance. The effective performance and the imagination of a task activates some overlapping central areas and neural networks, which might explain the improvements after motor imagery. The investigators set out to test the feasibility of such a study using an open label randomized cross-over trial including 32 persons aged 40 years or more. The primary aim is to evaluate whether the instructions are clear, the intervention and the study procedures are acceptable and to assess the proportion of participants withdraw from the study (drop outs). Secondary aims are the assessment of between group differences in the changes of the gait stability.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2016

Completed
22 days until next milestone

First Posted

Study publicly available on registry

February 29, 2016

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

August 6, 2019

Status Verified

August 1, 2019

Enrollment Period

5.3 years

First QC Date

February 7, 2016

Last Update Submit

August 5, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Composite Endpoint "feasibility"

    Combination of the following three parts: Part 1: one question about the understandability of the exercises Part 2: one question about the acceptability of the whole study process Part 3: Finishing the whole study: Did the participant finish the whole study, i.e. all three test sessions and at least some session of motor imagery exercises (based on the exercise calendar)?

    Immediately after the end of the both Intervention periods (week 6)

Secondary Outcomes (2)

  • Adherence to the motor imagery exercises

    Immediately after the end of the first intervention periods (week 3)

  • Change in the Lyapunov Exponent in the three acceleration axes "anterio-posterior", "medio-lateral" and "vertical"

    Immediately after the end of the first period (week 3)

Study Arms (2)

Control

NO INTERVENTION

Participants will be allowed to perform all usual activities but should refrain from performing the motor imagery exercises.

Motor imagery

EXPERIMENTAL

The motor imagery intervention is a non-pharmacological and non-invasive treatment often used in sport, music, or physical rehabilitation (Schuster, Hilfiker et al. 2011). Proposed tasks to be imagined by the participants are for example: "Imagine you are walking on ice. During the first steps, you are slipping quite often, but as you walk on, your steps become more stable and you walk without problems over the ice. Try to imagine how you react when you slip on ice, how you try not to fall and to continue to walk normally" The motor imagery intervention will be performed independently by the study participants at home without supervision three times a week for three weeks.

Other: Motor imagery

Interventions

The motor imagery intervention is a non-pharmacological and non-invasive treatment often used in sport, music, or physical rehabilitation (Schuster, Hilfiker et al. 2011). Proposed tasks to be imagined by the participants are for example: "Imagine you are walking on ice. During the first steps, you are slipping quite often, but as you walk on, your steps become more stable and you walk without problems over the ice. Try to imagine how you react when you slip on ice, how you try not to fall and to continue to walk normally" The motor imagery intervention will be performed independently by the study participants at home without supervision three times a week for three weeks.

Motor imagery

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old or older
  • Able to walk bout 100 meter, with or without walking aids, but without the help of a person or an ambulator

You may not qualify if:

  • Walking with an ambulator (Rollator)
  • No able to understand German

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hochschule für Gesundheit HES-SO Valais-Wallis

Leukerbad, Valais, 3954, Switzerland

RECRUITING

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Roger Hilfiker

    School of Health Sciences, HES-SO Valais-Wallis

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Roger Hilfiker

Study Record Dates

First Submitted

February 7, 2016

First Posted

February 29, 2016

Study Start

February 1, 2016

Primary Completion

June 1, 2021

Study Completion

September 1, 2021

Last Updated

August 6, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations