Neurological DisorderTONFITrehaNCT03598101
TONEFITreha: Proof of Concept and Usability Study.
A study testing TONEFITreha in people with Neurological Disorder and Orthopedic Disorder, run by Reha Rheinfelden at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurological Disorder, Orthopedic Disorder
- What is being tested?
- TONEFITreha
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2018to 30 Nov 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TONEFITreha: Proof of Concept and Usability of a Portable Exercise Device to Improve Cardiovascular Functioning and Balance in Neuro-orthopaedic Rehabilitation.
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.
- Conditions
- Neurological Disorder, Orthopedic Disorder
- Being tested
- TONEFITreha
- Medical subject headings
- Nervous System Diseases, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TONEFITrehaDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Not described Receives: Device: TONEFITreha |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3-4 weeks
Secondary outcomes (7)
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.
Measured: 3-4 weeks
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].
Measured: 3-4 weeks
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%.
Measured: 3-4 weeks
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.
Measured: At first visit (t+0) and prior to first training 2-4 days after first vist (t+2)
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.
Measured: At first visit (t+0) and prior to first training 2-4 days after first vist (t+2)
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.
Measured: At first visit (t+0 days) and prior to first training 2-4 days after first vist (t+2 days)
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).
Measured: At first visit (t+0 days) and prior to first training 2-4 days after first vist (t+2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Dec 2018
- Primary completion30 May 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reha Rheinfelden
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Behrendt, Reha Rheinfelden
- Investigators
- Frank A Behrendt, PhD, Principal investigator, Reha Rheinfelden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598101
- Sponsor's protocol ID
- 2018-00793
- Other IDs
- 2018
- Acronym
- TONFITreha
- Status last verified
- Apr 2020
- First submitted
- 18 Jun 2018
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TONEFITreha: Proof of Concept and Usability of a Portable Exercise Device to Improve Cardiovascular Functioning and Balance in Neuro-orthopaedic Rehabilitation.
- ClinicalTrials.gov ID
- NCT03598101
- Acronym / sponsor ID
- TONFITreha / 2018-00793
- Conditions
- Neurological Disorder, Orthopedic Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Reha RheinfeldenUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Device: TONEFITreha |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TONEFITrehaThe 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. | Device | Test group |
Primary outcome
Usability
Time frame: 3-4 weeks
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: 1. 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 2. 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). 3. 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).
7 secondary outcomes
Usability: Assists
Time frame: 3-4 weeks
Usability: Completion rate efficiency [%/s]
Time frame: 3-4 weeks
Usability: Goal achievement efficiency [%/s]
Time frame: 3-4 weeks
Proof-of-Concept: Measurement of covered walking distance with the built-in sensors.
Time frame: At first visit (t+0) and prior to first training 2-4 days after first vist (t+2)
Proof-of-Concept: Gait speed with the built-in sensors.
Time frame: At first visit (t+0) and prior to first training 2-4 days after first vist (t+2)
Proof-of-Concept: Increased intensity during walking (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)
Proof-of-Concept: Increased intensity during walking (heart rate)
Time frame: At first visit (t+0 days) and prior to first training 2-4 days after first vist (t+2 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Neurological Disorder
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank A Behrendt, PhD principal investigator
Reha Rheinfelden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TONEFITreha in people with Neurological Disorder and Orthopedic Disorder, run by Reha Rheinfelden 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 7 inclusion and 11 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 21 Apr 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?
Usability (time frame: 3-4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Apr 2020.