TONEFITreha: Proof of Concept and Usability Study.

NCT ID: NCT03598101

Last Updated: 2020-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2019-11-30

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.

Conditions

Neurological Disorder; Orthopedic Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Test group

Group Type: EXPERIMENTAL

TONEFITreha

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Reha Rheinfelden

OTHER

Sponsor Role: lead

Responsible Party

Frank Behrendt

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank A Behrendt, PhD

Role: PRINCIPAL_INVESTIGATOR

Reha Rheinfelden

Locations

Reha Rheinfelden

Rheinfelden, Canton of Aargau, Switzerland

Countries

Switzerland

Other Identifiers

2018-00793

Identifier Type: -

Identifier Source: org_study_id