Integrated Cognitive, Sensory, and Motor Rehabilitation of Hand Functions

NCT03349138 | Completed

• 1 other identifier: INCOGNITO
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaulates the addition to the standard theraphy of enriched sensorimotor training by means of robotic glove therapy, or functional electrical stimulation in the treatment of chronic stroke patients with upper limb motor impairments. All the patients receive the conventional physiotherapic treatment. Supplemental to the conventional treatment, patients are evenly split in four groups to provide different treatments for an equivalent amount of time. Patient in the first group receive supplemental conventional therapy; patients in the second group receive robotic glove therapy; patients in the third group receive functional electrical stimulation; patients in the fourth group receive robotic glove treatment and functional electrical stimulation in different sessions.

Conditions

Stroke

Keywords

rehabilitation; functional electrical stimulation; electrode array; upper limb; chronic; motor relearning

Outcome Measures

Primary Outcomes (1)

• Motricity Index

  Outcome measure to evaluate motor impairment after stroke; subscale for arm only; the subscale ranges from 0 (maximal impairment) to 100 (no impairment).

  9 weeks

Secondary Outcomes (5)

• Action Research Arm Test

  baseline; 9 weeks; 13 weeks.

• Medical Research Council

  baseline, 9 weeks, 13 weeks.

• Motor Activity Log

  baseline; 9 weeks; 13 weeks.

• Box & Blocks Test

  baseline; 9 weeks; 13 weeks.

• Modified Ashworth Scale

  baseline; 9 weeks; 13 weeks

Study Arms (4)

Conventional Therapy

ACTIVE COMPARATOR

27 sessions, 3 sessions per week for a total of 9 weeks. Each session lasts about 90 minutes and consists of different standard motor training modalities typically used in the rehabilitation of the arm after stroke. The training session is customized on the patients' need and can be adapted to their improvement during the intervention.

Device: Conventional Therapy

Robotic Glove

EXPERIMENTAL

Robotic Glove \& Conventional Therapy 27 sessions, 3 sessions per week for a total of 9 weeks. Each session consists of 30-minute training with the robotic glove system plus 60 minutes of conventional therapy. The training session is customized on the patients' need and can be adapted to their improvement during the intervention.

Device: Robotic Glove

Electrical Stimulation

EXPERIMENTAL

Electrical Stimulation \& Conventional Therapy 27 sessions, 3 sessions per week for a total of 9 weeks. Each session consists of 30-minute training with the electrical stimulation system plus 60 minutes of conventional therapy. The training session is customized on the patients' need and can be adapted to their improvement during the intervention.

Device: Electrical Stimulation

Electrical Stimulation and Robotic Glove

EXPERIMENTAL

Electrical Stimulation \& Robotic Glove \& Conventional Therapy 27 sessions, 3 sessions per week for a total of 9 weeks. Each session consists of 30-minute training with the electrical stimulation system plus 60 minutes of conventional therapy or 30-minute training with the robotic glove system plus 60 minutes of conventional therapy. Half of the sessions are allocated to the electrical stimulation system, and half are allocated to the robotic glove system. The training session is customized on the patients' need and can be adapted to their improvement during the intervention.

Device: Robotic Glove; Device: Electrical Stimulation

Interventions

Conventional Therapy DEVICE

Conventional Therapy

Robotic Glove DEVICE

Electrical Stimulation and Robotic Glove; Robotic Glove

Electrical Stimulation DEVICE

Electrical Stimulation; Electrical Stimulation and Robotic Glove

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults male and/or female, older than 18 years
• Patients who have suffered one or more strokes with major unilateral functional impairment
• Hemiplegic, left and right unilateral lesion
• Chronic phase of stroke at least six months before study enrollment
• Level of impairment: hand and/or arm
• No left handed
• Mini-Mental State Examination \> 20

You may not qualify if:

• Limitation for using the device due to impairment of Passive Range of Motion and/or
• Pain due to Spasticity evaluated using Modified Ashworth Scale (\>=3)
• Previous history of major neurological or psychiatric disorders
• allergy to electrodes

Sponsors & Collaborators

• Villa Beretta Rehabilitation Center: lead
• Ecole Polytechnique Fédérale de Lausanne: collaborator

Study Sites (1)

Villa Beretta Rehabilitation Center

Costa Masnaga, Lecco, 23845, Italy

Location

Related Publications (1)

• Crema A, Bassolino M, Guanziroli E, Colombo M, Blanke O, Serino A, Micera S, Molteni F. Neuromuscular electrical stimulation restores upper limb sensory-motor functions and body representations in chronic stroke survivors. Med. 2022 Jan 14;3(1):58-74.e10. doi: 10.1016/j.medj.2021.12.001. Epub 2022 Jan 7.

  PMID: 35590144 DERIVED

MeSH Terms

Conditions

Stroke; Bronchiolitis Obliterans Syndrome

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Franco Molteni, MD

  Villa Beretta Rehabilitation Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director

Model Details: Conventional treatment allocated to patients in all arms. Supplemental dose matched treatment to each of the four arms (9 weeks, 3 treatments a week) as follows: * conventional treatment (27 treatments) * functional electrical stimulation (27 treatments) * robotic glove ( 27 treatments ) * robotic glove and electrical stimulation ( each session uses one device, half of the sessions uses the robotic glove, half the functional electrical stimulation )

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 21, 2017
• Study Start: January 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: August 31, 2017
• Last Updated: November 24, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)