An interventional study of TONEFITreha in Neurological Disorder and Orthopedic Disorder, sponsored by Reha Rheinfelden. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-21.
Sponsored by Reha Rheinfelden · Not applicable, Interventional, and Device feasibility
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.
757 studies on the registry are indexed under Nervous System Diseases; 218 are open to participants now.
This study's enrollment of 9 is below the median of 55 across 495 interventional studies indexed under Nervous System Diseases.
Browse Nervous System Diseases studies →Reha Rheinfelden is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: TONEFITreha
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.
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: 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).
Time frame: 3-4 weeks
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.
Time frame: 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 \[s\].
Time frame: 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%.
Time frame: 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.
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.
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)
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.
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)
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)
Experience with walking exercises
The amount of experience with walking exercise (qualitative, verbal description or as hours/week, if applicable),
Time frame: At first visit (t+0 days).
General attitude towards technology based exercise:
- 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).
Demographics: Age
Age in years.
Time frame: At first visit (t+0 days).
Demographics: Weight and height reported as BMI [kg/m^2]
Weight \[kg\] and height \[m\] in BMI \[kg/m\^2\]
Time frame: At first visit (t+0 days).
Demographics: Profession
Profession (qualitative description)
Time frame: At first visit (t+0 days).
Attrition
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.
Adherence
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.
Exercise diary:
Training duration and intensity will be derived from the smartphone interface.
Time frame: 3-4 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2018 to primary completion in May 2019, 5 months.
Of 167 non-industry interventional studies with no phase under Nervous System Diseases, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 57. This study's 5 months is below that.
Counting every sponsor, half of 193 studies reached it within 30 months; a quarter within 11 and three quarters within 57.
Nervous System Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Reha Rheinfelden