Clinical trial NCT03598101: TONEFITreha: Proof of Concept and Usability Study.
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
Overall status: COMPLETED
Phase: NA
Conditions: Neurological Disorder
Orthopedic Disorder
Lead sponsor: Reha Rheinfelden
Sponsor class: OTHER
First posted: 2018-07-26
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


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.

Primary outcomes:
measure: Usability
timeFrame: 3-4 weeks
Secondary outcomes:
measure: Usability: Assists
timeFrame: 3-4 weeks
measure: Usability: Completion rate efficiency [%/s]
timeFrame: 3-4 weeks
measure: Usability: Goal achievement efficiency [%/s]
timeFrame: 3-4 weeks
measure: Proof-of-Concept: Measurement of covered walking distance with the built-in sensors.
timeFrame: At first visit (t+0) and prior to first training 2-4 days after first vist (t+2)
measure: Proof-of-Concept: Gait speed with the built-in sensors.
timeFrame: At first visit (t+0) and prior to first training 2-4 days after first vist (t+2)
measure: Proof-of-Concept: Increased intensity during walking (VCO2/VO2 relationship)
timeFrame: At first visit (t+0 days) and prior to first training 2-4 days after first vist (t+2 days)
measure: Proof-of-Concept: Increased intensity during walking (heart rate)
timeFrame: At first visit (t+0 days) and prior to first training 2-4 days after first vist (t+2 days)
Other outcomes:
measure: Experience with walking exercises
timeFrame: At first visit (t+0 days).
measure: General attitude towards technology based exercise:
timeFrame: At first visit (t+0 days).
measure: Demographics: Age
timeFrame: At first visit (t+0 days).
measure: Demographics: Weight and height reported as BMI [kg/m^2]
timeFrame: At first visit (t+0 days).
measure: Demographics: Profession
timeFrame: At first visit (t+0 days).
measure: Attrition
timeFrame: 3 to 4 weeks after first visit.
measure: Adherence
timeFrame: 3 to 4 weeks after first visit.
measure: Exercise diary:
timeFrame: 3-4 weeks
Locations:
city: Rheinfelden
country: Switzerland
facility: Reha Rheinfelden
state: Aargau
Study officials:
affiliation: Reha Rheinfelden
name: Frank A Behrendt, PhD
role: PRINCIPAL_INVESTIGATOR
References: