TONEFITreha: Proof of Concept and Usability Study.

NCT03598101 | Completed

• 1 other identifier: 2018-00793
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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).

  3-4 weeks

Secondary Outcomes (7)

• Usability: Assists

  3-4 weeks

• Usability: Completion rate efficiency [%/s]

  3-4 weeks

• Usability: Goal achievement efficiency [%/s]

  3-4 weeks

• Proof-of-Concept: Measurement of covered walking distance with the built-in sensors.

  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.

  At first visit (t+0) and prior to first training 2-4 days after first vist (t+2)

Other Outcomes (8)

• Experience with walking exercises

  At first visit (t+0 days).

• General attitude towards technology based exercise:

  At first visit (t+0 days).

• Demographics: Age

  At first visit (t+0 days).

Study Arms (1)

Test group

EXPERIMENTAL

Device: TONEFITreha

Interventions

TONEFITreha 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.

Test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reha Rheinfelden: lead

Study Sites (1)

Reha Rheinfelden

Rheinfelden, Canton of Aargau, 4310, Switzerland

Location

MeSH Terms

Conditions

Nervous System Diseases; Musculoskeletal Diseases

Study Officials

• Frank A Behrendt, PhD

  Reha Rheinfelden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: July 26, 2018
• Study Start: December 1, 2018
• Primary Completion: May 30, 2019
• Study Completion: November 30, 2019
• Last Updated: April 21, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)