Clinical Feasibility of Minimally Supervised Therapy After Stroke With a Hand Rehabilitation Robot

NCT04388891 | Completed

• 1 other identifier: ReHapticKnob 2020
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The ReHapticKnob is a robot for hand rehabilitation after stroke. We aim to investigate the feasibility of minimally supervised therapy with the ReHapticKnob with stroke patients in a rehabilitation clinic, evaluate the usability of the ReHapticKnob (user interface and implemented exercises which were adapted for independent usage), and quantify the dose of additional robotic therapy that patients perform in a minimally supervised setting. Minimally supervised therapy means that after a training phase, where the therapists teach to the patients how to perform the exercises with the robot, the patients can autonomously train with the robot during free time without being directly supervised. Our hypothesis is that minimally supervised therapy might be a possible way to increase therapy dose for stroke patients, with the potential to further improve recovery of hand function with minimal additional burden for therapists and for the healthcare system.

Conditions

Stroke

Keywords

Stroke; Hand impairment; Robot-assisted therapy; Minimally supervised therapy; Neurorehabilitation

Outcome Measures

Primary Outcomes (1)

• Compliance as assessed by dose

  Sum of the dose of robot-assisted therapy without direct supervision that the patient performs.

  Compliance to minimally supervised therapy is calculated at the end of the fourth week of the study protocol.

Secondary Outcomes (18)

• Usability as assessed by the Post-Study System Usability Questionnaire

  Usability is first measured at the end of the second week.

• Usability as assessed by the Post-Study System Usability Questionnaire

  Usability is measured again at the end of the fourth week.

• Usability as assessed by the System Usability Scale

  Usability is first measured at the end of the second week.

• Usability as assessed by the System Usability Scale

  Usability is measured again at the end of the fourth week.

• Usability as assessed by the NASA Task Load Index

  Usability is first measured at the end of the second week.

Study Arms (1)

Minimally supervised therapy

EXPERIMENTAL

This group will undergo minimally supervised therapy with the robot ReHapticKnob.

Device: Minimally supervised therapy with the ReHapticKnob

Interventions

Minimally supervised therapy with the ReHapticKnob DEVICE

The therapy with the ReHapticKnob is performed in the clinic in addition to the conventional therapy. During the supervised and semi-supervised phases (first 2 weeks), the intervention dose is 5 sessions of approximately 45 minutes per week. During each session, the robot proposes a set of 3 exercises, each lasting between 10 and 15 minutes. During the minimally supervised phase (third and fourth week), the duration of the ReHapticKnob therapy is not specified, since the patient can decide by him/herself when to use the device, e.g. during freetime or during the weekend.

Minimally supervised therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female stroke patients between 18 and 90 years old;
• pre-stroke Modified Rankin Score ≤ 1;
• acute/subacute stroke (within (≤) 6 weeks from onset);
• NIHSS ≥ 1 in at least one of the items regarding motor function, sensory functions and ataxia;
• the patient read, understood and signed the informed consent.

You may not qualify if:

• Modified Ashworth Scale \> 2 for one or more of the following muscles: shoulder adductors, forearm pronator and supinator, flexors and extensors of elbow, wrist and fingers;
• moderate to severe aphasia: Goodglass-Kaplan scale \< 3;
• moderate to severe cognitive deficits: levels of cognitive functioning-revised (LCF-R) \< 8;
• functional impairment of the upper limb due to other pathologies;
• severe pain in the affected arm: visual analogue scale for pain (VASp) ≥ 5;
• other pathologies which may interfere with the study;
• pacemakers and other active implants.

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Clinica Hildebrand Brissago: collaborator
• Rehabilitation Engineering Laboratory, ETHZ: collaborator

Study Sites (1)

Clinica Hildebrand Centro di riabiliazione Brissago

Brissago, Canton Ticino, 6614, Switzerland

Location

Related Publications (2)

• Devittori G, Dinacci D, Romiti D, Califfi A, Petrillo C, Rossi P, Ranzani R, Gassert R, Lambercy O. Unsupervised robot-assisted rehabilitation after stroke: feasibility, effect on therapy dose, and user experience. J Neuroeng Rehabil. 2024 Apr 9;21(1):52. doi: 10.1186/s12984-024-01347-4.

  PMID: 38594727 DERIVED

• Devittori G, Ranzani R, Dinacci D, Romiti D, Califfi A, Petrillo C, Rossi P, Gassert R, Lambercy O. Progressive Transition From Supervised to Unsupervised Robot-Assisted Therapy After Stroke: Protocol for a Single-Group, Interventional Feasibility Study. JMIR Res Protoc. 2023 Nov 9;12:e48485. doi: 10.2196/48485.

  PMID: 37943580 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Paolo Rossi, Dr. med.

  Clinica Hildebrand Brissago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 14, 2020
• Study Start: August 11, 2020
• Primary Completion: September 14, 2023
• Study Completion: September 14, 2023
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)