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

NCT ID: NCT04388891

Last Updated: 2024-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-11
• Study Completion Date: 2023-09-14

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

Study Design

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

Study Groups

Minimally supervised therapy

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

Group Type: EXPERIMENTAL

Minimally supervised therapy with the ReHapticKnob

Intervention Type: 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.

Interventions

Minimally supervised therapy with the ReHapticKnob

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinica Hildebrand Brissago

OTHER

Sponsor Role: collaborator

Rehabilitation Engineering Laboratory, ETHZ

UNKNOWN

Sponsor Role: collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paolo Rossi, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Clinica Hildebrand Brissago

Locations

Clinica Hildebrand Centro di riabiliazione Brissago

Brissago, Canton Ticino, Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 38594727 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37943580 (View on PubMed)

Other Identifiers

ReHapticKnob 2020

Identifier Type: -

Identifier Source: org_study_id