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Home-based Motor Imagery for Gait Stability in Older Adults. A Cross-over Feasibility Study. (MIGS-F) (MIGS-F)

Primary Purpose

Gait, Unsteady

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Motor imagery
Sponsored by
University of Applied Sciences of Western Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gait, Unsteady

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 40 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

Exclusion Criteria:

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

Sites / Locations

  • Hochschule für Gesundheit HES-SO Valais-WallisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Motor imagery

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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)?

Secondary Outcome Measures

Adherence to the motor imagery exercises
The adherence to the motor imagery exercises will be assessed with a exercise calendar with a sheet for each of the three weeks. On each day of the calendar the exercises were shortly described and the participants can just check whether he has done that exercise and can state how many minute he or she has exercises that day (only motor imagery exercises).
Change in the Lyapunov Exponent in the three acceleration axes "anterio-posterior", "medio-lateral" and "vertical"
The "first" endpoint for effectiveness is the change in the Lyapunov Exponent in the three acceleration axes "anterio-posterior", "medio-lateral" and "vertical". The Lyapunov Exponent is calculated based on the 4 times 30 meter walk test in normal speed. For these tests, the participants wear normal clothes and normal shoes (same shoes at all three test sessions). The test will be performed in a 35 meter long corridor. The participant starts walking with his normal speed, walks 30 meters and stops. He turns 180°, waits ten seconds and starts walking again the 30 meters. He repeats this until he has four series of 30 meters. The data will be stored after each participant on a portable computer in coded form. The Lyapunov Exponent is then calculated later in R (statistical software) and the mean over all four series is taken.

Full Information

First Posted
February 7, 2016
Last Updated
August 5, 2019
Sponsor
University of Applied Sciences of Western Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT02693756
Brief Title
Home-based Motor Imagery for Gait Stability in Older Adults. A Cross-over Feasibility Study. (MIGS-F)
Acronym
MIGS-F
Official Title
Home-based Motor Imagery Intervention for the Improvement of Gait Stability in Elderly Persons. A Cross-over Feasibility Study.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Applied Sciences of Western Switzerland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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. These "non-physical kind of training" modalities could be used in patients who are immobilized temporarily (bedridden because of non-chronic disease, infection etc.), or in those who are not allowed to charge their leg normally (e.g. postoperative phase of joint replacement or fractures), or it can be used in combination with physical exercises, or in the preparation of the physical exercise training (either skilling up phase or as a preparation to increase safety of physical exercises). In persons above 40 years of age, motor imagery could provide a sound exercise modality for tasks that are not easy to perform with real performance. For example, walking on slippery underground such as ice, walking on a small trail in some altitude, avoiding running dogs or cats on a sidewalk, or catching up after stumbling can be either difficult to exercise in reality or might be too dangerous in reality. Imaging one's performance in such difficult environments or situations might lead to better gait stability, improved reactions in these situations and thus probably to reduced falls frequency. Gait stability can be estimated with the local dynamic stability, which is based on chaos theory, i.e. the maximal Lyapunov exponent, is strongly influenced by the sensorimotor balance system and is widely used for measuring gait stability. In the future, the investigators plan a large scale randomized open label cross-over study to test whether nine sessions of motor imagery improve walking stability, measured with the Lyapunov Exponent. To prepare this future study, the investigators set out to test the feasibility of such a study with a feasibility 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait, Unsteady

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants will be allowed to perform all usual activities but should refrain from performing the motor imagery exercises.
Arm Title
Motor imagery
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Motor imagery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite Endpoint "feasibility"
Description
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)?
Time Frame
Immediately after the end of the both Intervention periods (week 6)
Secondary Outcome Measure Information:
Title
Adherence to the motor imagery exercises
Description
The adherence to the motor imagery exercises will be assessed with a exercise calendar with a sheet for each of the three weeks. On each day of the calendar the exercises were shortly described and the participants can just check whether he has done that exercise and can state how many minute he or she has exercises that day (only motor imagery exercises).
Time Frame
Immediately after the end of the first intervention periods (week 3)
Title
Change in the Lyapunov Exponent in the three acceleration axes "anterio-posterior", "medio-lateral" and "vertical"
Description
The "first" endpoint for effectiveness is the change in the Lyapunov Exponent in the three acceleration axes "anterio-posterior", "medio-lateral" and "vertical". The Lyapunov Exponent is calculated based on the 4 times 30 meter walk test in normal speed. For these tests, the participants wear normal clothes and normal shoes (same shoes at all three test sessions). The test will be performed in a 35 meter long corridor. The participant starts walking with his normal speed, walks 30 meters and stops. He turns 180°, waits ten seconds and starts walking again the 30 meters. He repeats this until he has four series of 30 meters. The data will be stored after each participant on a portable computer in coded form. The Lyapunov Exponent is then calculated later in R (statistical software) and the mean over all four series is taken.
Time Frame
Immediately after the end of the first period (week 3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 40 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 Exclusion Criteria: Walking with an ambulator (Rollator) No able to understand German
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roger Hilfiker
Phone
0041 79 688 34 90
Email
roger.hilfiker@hevs.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Hilfiker
Organizational Affiliation
School of Health Sciences, HES-SO Valais-Wallis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hochschule für Gesundheit HES-SO Valais-Wallis
City
Leukerbad
State/Province
Valais
ZIP/Postal Code
3954
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roger Hilfiker
Phone
0041796883490

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Home-based Motor Imagery for Gait Stability in Older Adults. A Cross-over Feasibility Study. (MIGS-F)

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