TONEFITreha: Proof of Concept and Usability Study. (TONFITreha)

R

Reha Rheinfelden

Status

Completed

Conditions

Orthopedic Disorder
Neurological Disorder

Treatments

Device: TONEFITreha

Study type

Interventional

Funder types

Other

Identifiers

NCT03598101
2018-00793

Details and patient eligibility

About

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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Device Feasibility

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

9 participants in 1 patient group

Test group
Experimental group
Treatment:
Device: TONEFITreha

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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