Clinical Validation of an Instrumented Glove for Sensorimotor Rehabilitation

Condition(s) studied

Investigational drug(s) / intervention(s)

DESC-Glove (active): Rehabilitation treatment for the upper limb using the DESC-Glove device. The protocol includes 8 exercises, each lasting 2 to 3 minutes. The treatment is conducted daily under the supervision of a therapist and consists of two 20-minute sessions per day, with a 10-minute break in between for neuro-muscular and attentional recovery. The treatment is performed three times a week, totaling 24 sessions over a 4-week period. During each session, patients will wear the DESC-Glove on the affected hand, receiving vibratory stimuli that are synchronized with the exercises being performed.

DESC-Glove (sham): Rehabilitation treatment for the upper limb using the DESC-Glove device. The protocol includes 8 exercises, each lasting 2 to 3 minutes. The treatment is conducted daily under the supervision of a therapist and consists of two 20-minute sessions per day, with a 10-minute break in between for neuro-muscular and attentional recovery. The treatment is performed three times a week, totaling 24 sessions over a 4-week period. During each session, patients will wear the DESC-Glove on the affected hand, but will not receive any vibratory stimuli.

Traditional rehabilitation: Traditional rehabilitation treatment for the upper limb. The protocol includes 8 exercises, each lasting 2 to 3 minutes. The treatment is conducted daily under the supervision of a therapist and consists of two 20- minute sessions per day, with a 10-minute break in between for neuro-muscular and attentional recovery. The treatment is performed three times a week, totaling 24 sessions over a 4-week period. The DESC- Glove will not be used during this treatment.

Study summary

The goal of this clinical trial is to evaluate the DESC-Glove, an instrumented glove developed for sensorimotor rehabilitation in individuals recovering from a stroke, utilizing non-invasive vibrational feedback. The primary objective is to assess the technical functionality, safety, and reliability of the device during post-stroke rehabilitation, providing insights for future technical and functional improvements.

The secondary objectives are:

1. To evaluate the usability and acceptability of the device in clinical rehabilitation from the perspectives of both patients and healthcare professionals;
2. To assess the short-term effects of the DESC-Glove on sensorimotor performance and manual dexterity in post-stroke individuals.

To meet the second objective, researchers will compare three groups:

an experimental treatment group (using the DESC-Glove during hand rehabilitation), a sham control group (using the DESC-Glove without vibration), and a conventional control group (receiving hand rehabilitation without the device).

Eligibility

Primary outcome measure(s)

• Device malfunctioning: number and types of device malfunctions — For both the first and second phase of the study: within one day after each rehabilitation session.
  This outcome measure is designed to systematically document and analyze any malfunctions of the DESC-Glove device throughout the study. All malfunctions will be recorded in detail, including the frequency and type of malfunction. Each issue will be categorized based on the nature of the malfunction, such as hardware failures (e.g., sensor or vibration issues), software, or connectivity problems. This data will be used to assess the overall reliability and functionality of the device, guiding future improvements and treatment efficacy.
• Device malfunctioning: number of dropouts device-related — For both the first and second phase of the study: within one day after each rehabilitation session.
  This outcome measure aims to document the number of participants who withdraw from the study specifically due to issues related to the device.

Trial sites (6)

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