Back to resultsTONEFITreha: Proof of Concept and Usability Study. (TONFITreha)
Primary Purpose
Neurological Disorder, Orthopedic Disorder
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
TONEFITreha
Sponsored by
About this trial
This is an interventional device feasibility trial for Neurological Disorder
Eligibility Criteria
Inclusion Criteria:
- In-patients with non-specified pathological background
- At trial centre for at least 2 weeks
- If less than 4 weeks, willingness to visit clinic for the remaining exercise sessions.
- Must be able to walk independently (no or minimal gait impairment)
- Deemed fit for walking group exercise and other exercise (medical expert opinion).
- Cleared for low-intensity endurance exercise by treating physicians and therapists (medical expert opinion).
- Informed Consent as documented by signature (Appendix Informed Consent Form).
Exclusion Criteria:
- Health condition does not allow free movements of body segments (e.g. un-consolidated upper limb fracture)
- Contraindications to low-intensity endurance training (e.g. congestive heart failure, unstable angina, peripheral arterial occlusive disease).
- Fresh wounds around waist and trunk.
- Orthopaedic condition that limits walking ability (e.g. newly operated total hip replacement).
- Women who are pregnant or breast feeding,
- Intention to become pregnant during the course of the study
- Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable double-barrier method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, combined with mechanical barriers (e.g. condoms or diaphragms) or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
- Known or suspected non-compliance, drug or alcohol abuse,
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant (derived from medical history),
- Previous enrolment into the current study,
- Enrolment of the investigator, his/her family members, employees and other dependent persons.
Sites / Locations
- Reha Rheinfelden
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Test group
Arm Description
Outcomes
Primary Outcome Measures
Usability
Participants will be asked to rate the perceived usability based on the System Usability Scale (SUS). SUS assesses perceived effectiveness (can users successfully achieve their objectives), information quality (how much effort and resource is expended in achieving those objectives) and general satisfaction (was the experience satisfactory). The SUS hast 10 items that can be rated on a 5-point likert scale. The items will be scored as follows:
For odd-numbered items, user response-1. For even-numbered items 5-user response. This scales all values from 0 to 4 (with four being the most positive response). Ref: Jeff Sauro, measuring usability
Add up the converted responses for each user and multiply that total by 2.5 (to convert the range of possible values from 0 to 100 instead of from 0 to 40).
single missing values are replaced with a neutral 3. Normative values will be used to grade the achieved median score (A through D, with D being least acceptable grade).
Secondary Outcome Measures
Usability: Assists
Each participant will have a list of tasks to be completed per session. Amount of additional assistance following the introduction (after three supervised sessions), will be counted as outcome. E.g. additional verbal cues or practical assistance.
Usability: Completion rate efficiency [%/s]
Each participant will have a list of tasks to be completed per session. mean completion rate/mean task time = completion rate efficiency [%/s]; e.g. 80% completed all tasks within an average of 360 seconds.
Task time: mean time taken before training was started [s].
Usability: Goal achievement efficiency [%/s]
Each participant will have a list of tasks to be completed per session. mean goal achievement/mean task time = Goal achievement efficiency [%/s]; e.g. 43% completed in 360 seconds Mean goal achievement: Mean extent to which the tasks were completed [%], e.g. 3 out of 7 tasks completed correctly = 43%.
Proof-of-Concept: Measurement of covered walking distance with the built-in sensors.
Standardised clinical assessment often employed as part of routine assessments will be used. The 10 Meter Walk Test (10MWT) is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.
Proof-of-Concept: Gait speed with the built-in sensors.
A second standardised clinical assessment often employed as part of routine assessments will be used. The 6 Minute Walk Test (6MWT) is a sub-maximal exercise test used to assess aerobic capacity and endurance.
Proof-of-Concept: Increased intensity during walking (VCO2/VO2 relationship)
Cardiopulmonary response will be measured using a breath-by-breath cardiorespiratory monitoring system (MetaMax 3B, Cortex Biophysik, Leipzig, Germany) and a receiver board (HRMI, Sparkfun, Boulder, USA). During 10 meter walk test and a 6-minute walk test, oxygen uptake (VO2) and carbon dioxide output (VCO2) will be recorded and reported and VCO2/VO2 relationship.
Proof-of-Concept: Increased intensity during walking (heart rate)
During 10 meter walk test and a 6-minute walk test, heart rate (HR) will be recorded in both conditions (with and without belt). HR will be recorded over a rate belt (T31, Polar Electro, Kempele, Finland).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03598101
Brief Title
TONEFITreha: Proof of Concept and Usability Study.
Acronym
TONFITreha
Official Title
TONEFITreha: Proof of Concept and Usability of a Portable Exercise Device to Improve Cardiovascular Functioning and Balance in Neuro-orthopaedic Rehabilitation.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
May 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Reha Rheinfelden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The importance of physical activity and exercise-based interventions in neuro-orthopaedic rehabilitation is undisputed. Yet, patients and clinicians do not implement minimally required doses of physical activity in standard rehabilitation programs. This is partly due to intrinsic factors such as motivation, or due to physical condition that prevent any kind of exercise. In most cases, however, it is owed to limited time spent with therapists who would be able to supervise and apply the required doses to induce any potential exercise effects. Methods to semi-autonomously exercise with high motivation and continuous feedback would complement existing therapies and allow adherence to minimal dose recommendations.
For this study, a prototype of a new portable training solution for intensive walking exercise with built-in sensor-technology and a smartphone interface will be tested regarding its usability and its efficiency in a clinical setting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurological Disorder, Orthopedic Disorder
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
TONEFITreha
Intervention Description
The newly developed Tonefit Reha is based on the existing fitness device, the TONEFIT belt. Similar to Nordic Walking, the device aims to include upper limb activity in walking exercise to train the shoulder girdle and arm. While Nordic Walking uses poles, the existing TONEFIT belt uses body-worn resistance handles to actively involve the upper body. It is worn around the waist, like a belt. The two independent pull-push elements with non-adjustable resistance on each side allow increased intensity for strengthening and endurance training during walking, particular for upper extremities and trunk stability.
Primary Outcome Measure Information:
Title
Usability
Description
Participants will be asked to rate the perceived usability based on the System Usability Scale (SUS). SUS assesses perceived effectiveness (can users successfully achieve their objectives), information quality (how much effort and resource is expended in achieving those objectives) and general satisfaction (was the experience satisfactory). The SUS hast 10 items that can be rated on a 5-point likert scale. The items will be scored as follows:
For odd-numbered items, user response-1. For even-numbered items 5-user response. This scales all values from 0 to 4 (with four being the most positive response). Ref: Jeff Sauro, measuring usability
Add up the converted responses for each user and multiply that total by 2.5 (to convert the range of possible values from 0 to 100 instead of from 0 to 40).
single missing values are replaced with a neutral 3. Normative values will be used to grade the achieved median score (A through D, with D being least acceptable grade).
Time Frame
3-4 weeks
Secondary Outcome Measure Information:
Title
Usability: Assists
Description
Each participant will have a list of tasks to be completed per session. Amount of additional assistance following the introduction (after three supervised sessions), will be counted as outcome. E.g. additional verbal cues or practical assistance.
Time Frame
3-4 weeks
Title
Usability: Completion rate efficiency [%/s]
Description
Each participant will have a list of tasks to be completed per session. mean completion rate/mean task time = completion rate efficiency [%/s]; e.g. 80% completed all tasks within an average of 360 seconds.
Task time: mean time taken before training was started [s].
Time Frame
3-4 weeks
Title
Usability: Goal achievement efficiency [%/s]
Description
Each participant will have a list of tasks to be completed per session. mean goal achievement/mean task time = Goal achievement efficiency [%/s]; e.g. 43% completed in 360 seconds Mean goal achievement: Mean extent to which the tasks were completed [%], e.g. 3 out of 7 tasks completed correctly = 43%.
Time Frame
3-4 weeks
Title
Proof-of-Concept: Measurement of covered walking distance with the built-in sensors.
Description
Standardised clinical assessment often employed as part of routine assessments will be used. The 10 Meter Walk Test (10MWT) is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.
Time Frame
At first visit (t+0) and prior to first training 2-4 days after first vist (t+2)
Title
Proof-of-Concept: Gait speed with the built-in sensors.
Description
A second standardised clinical assessment often employed as part of routine assessments will be used. The 6 Minute Walk Test (6MWT) is a sub-maximal exercise test used to assess aerobic capacity and endurance.
Time Frame
At first visit (t+0) and prior to first training 2-4 days after first vist (t+2)
Title
Proof-of-Concept: Increased intensity during walking (VCO2/VO2 relationship)
Description
Cardiopulmonary response will be measured using a breath-by-breath cardiorespiratory monitoring system (MetaMax 3B, Cortex Biophysik, Leipzig, Germany) and a receiver board (HRMI, Sparkfun, Boulder, USA). During 10 meter walk test and a 6-minute walk test, oxygen uptake (VO2) and carbon dioxide output (VCO2) will be recorded and reported and VCO2/VO2 relationship.
Time Frame
At first visit (t+0 days) and prior to first training 2-4 days after first vist (t+2 days)
Title
Proof-of-Concept: Increased intensity during walking (heart rate)
Description
During 10 meter walk test and a 6-minute walk test, heart rate (HR) will be recorded in both conditions (with and without belt). HR will be recorded over a rate belt (T31, Polar Electro, Kempele, Finland).
Time Frame
At first visit (t+0 days) and prior to first training 2-4 days after first vist (t+2 days)
Other Pre-specified Outcome Measures:
Title
Experience with walking exercises
Description
The amount of experience with walking exercise (qualitative, verbal description or as hours/week, if applicable),
Time Frame
At first visit (t+0 days).
Title
General attitude towards technology based exercise:
Description
- attitude towards technology and the use of sensors (visual analogue scale, VAS, 0 to 100mm, where 0 stands for 'negative attitude' and 100 for 'positive attitude'),
Time Frame
At first visit (t+0 days).
Title
Demographics: Age
Description
Age in years.
Time Frame
At first visit (t+0 days).
Title
Demographics: Weight and height reported as BMI [kg/m^2]
Description
Weight [kg] and height [m] in BMI [kg/m^2]
Time Frame
At first visit (t+0 days).
Title
Demographics: Profession
Description
Profession (qualitative description)
Time Frame
At first visit (t+0 days).
Title
Attrition
Description
For attrition, the number of participants lost during the intervention was recorded. For adherence, participants' engagement with the intervention will be assessed.
Time Frame
3 to 4 weeks after first visit.
Title
Adherence
Description
Adherence will be calculated as the number of completed training sessions as a percentage of the maximal possible training sessions.
Time Frame
3 to 4 weeks after first visit.
Title
Exercise diary:
Description
Training duration and intensity will be derived from the smartphone interface.
Time Frame
3-4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
In-patients with non-specified pathological background
At trial centre for at least 2 weeks
If less than 4 weeks, willingness to visit clinic for the remaining exercise sessions.
Must be able to walk independently (no or minimal gait impairment)
Deemed fit for walking group exercise and other exercise (medical expert opinion).
Cleared for low-intensity endurance exercise by treating physicians and therapists (medical expert opinion).
Informed Consent as documented by signature (Appendix Informed Consent Form).
Exclusion Criteria:
Health condition does not allow free movements of body segments (e.g. un-consolidated upper limb fracture)
Contraindications to low-intensity endurance training (e.g. congestive heart failure, unstable angina, peripheral arterial occlusive disease).
Fresh wounds around waist and trunk.
Orthopaedic condition that limits walking ability (e.g. newly operated total hip replacement).
Women who are pregnant or breast feeding,
Intention to become pregnant during the course of the study
Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable double-barrier method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, combined with mechanical barriers (e.g. condoms or diaphragms) or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
Known or suspected non-compliance, drug or alcohol abuse,
Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant (derived from medical history),
Previous enrolment into the current study,
Enrolment of the investigator, his/her family members, employees and other dependent persons.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank A Behrendt, PhD
Organizational Affiliation
Reha Rheinfelden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reha Rheinfelden
City
Rheinfelden
State/Province
Aargau
ZIP/Postal Code
4310
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
TONEFITreha: Proof of Concept and Usability Study.
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