Feasibility and Efficacy of a Robotic Device for Hand Rehabilitation

NCT ID: NCT02628418

Last Updated: 2016-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-06-30

Brief Summary

Hand recovery following cerebral stroke is complex and requires intensive training. The investigators aimed to evaluate the feasibility and efficacy of robot-assisted hand rehabilitation compared to physiotherapist-guided treatment in recovering dexterity and hand strength in hospitalized sub-acute hemiplegic patients. Design. 30 patients affected by stroke from cerebral ischemia or hemorrhage (Ashworth spasticity index <3) were randomized. Patients in the Treatment group received intensive hand training with Gloreha, a hand rehabilitation glove that provides computer-controlled, repetitive, passive mobilization of the fingers, with multisensory feedback. Patients in the Control group received conventional intensive hand rehabilitation under physiotherapist guidance. Hand motor function (Motricity Index, MI), fine manual dexterity (Nine Hole Peg Test, NHPT) and strength (Grip and Pinch test) were measured at baseline and after rehabilitation, and the differences between final and basal results were compared between groups.

Detailed Description

Upper limb recovery, particularly that of the hand, is complex in patients with cerebral stroke and requires an intensive approach.

Regarding upper limb rehabilitation, several research groups have developed robotic devices to provide passive and/or active movements. Their use appears to reduce the motor deficit of the arm and affected hand and to improve hand function both at the wrist and fingers. Hence, the evidence supporting specific robot-assisted rehabilitation of the hand is very promising even if further study is required.In particular, evidence is limited about the benefit of passive exercises and mobilization of the hemiplegic upper limb following stroke, and further research is called for.

In this study the investigators used Gloreha, a new hand rehabilitation glove that provides computer-controlled, repetitive and passive mobilization of the fingers, with multi-sensory feedback. The purpose of the study was to evaluate in the rehabilitation of patients with ischemic or hemorrhagic stroke in the sub-acute phase: 1) the feasibility of this new neuromotor rehabilitation device 2) its efficacy in improving arm function abilities, and 3) the costs involved.

Post-stroke patients admitted for inpatient rehabilitation between May 2013 and January 2014 were screened for enrollment. Eligible patients were randomly assigned, following a simple randomization procedure (computerized random numbers) conducted independently of the study investigators, to Treatment group or Control group, on a 1:1 ratio.

Conditions

Stroke; Upper Extremity Hemiplegia; Disorder of Hand

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gloreha Group

The patients in the "Gloreha Group" underwent to following interventions:

1. General Rehabilitation

2. Specific hand rehabilitation by Gloreha device

Group Type: EXPERIMENTAL

General Rehabilitation

Intervention Type: OTHER

All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.

Specific hand rehabilitation by Gloreha device

Intervention Type: DEVICE

Each training session consisted of six parts:

1. A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min);

2. 7 min of a number sequence (counting from one to five);

3. A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min)

4. A sequence of wave-like finger movements (7 min)

5. A sequence of fist opening/closing (7 min)

6. A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min).

Control Group

The patients in the Control Group underwent to following interventions:

1. General Rehabilitation

2. Specific hand rehabilitation performed by physiotherapist

Group Type: OTHER

General Rehabilitation

Intervention Type: OTHER

All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.

Specific hand rehabilitation performed by physiotherapist

Intervention Type: OTHER

The activities were:

1. Flexion-extension of the fingers (10 min);

2. Thumb opposition with the other fingers keeping the forearm in supine position (10 min);

3. Adduction and abduction of the fingers (10 min);

4. Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min).

Interventions

General Rehabilitation

All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.

Intervention Type: OTHER

Specific hand rehabilitation by Gloreha device

Each training session consisted of six parts:

1. A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min);

2. 7 min of a number sequence (counting from one to five);

3. A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min)

4. A sequence of wave-like finger movements (7 min)

5. A sequence of fist opening/closing (7 min)

6. A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min).

Intervention Type: DEVICE

Specific hand rehabilitation performed by physiotherapist

The activities were:

1. Flexion-extension of the fingers (10 min);

2. Thumb opposition with the other fingers keeping the forearm in supine position (10 min);

3. Adduction and abduction of the fingers (10 min);

4. Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients affected by stroke from cerebral ischemia or hemorrhage that had occurred ≤ 30 days before, with Ashworth spasticity index < 3.

Exclusion Criteria

• orthopedic limitation (amputations, irreducible articular limitations, advanced osteoarthritis, active rheumatoid arthritis);
• peripheral nerve injury;
• uncontrolled inflammation;
• severe cognitive and behavioral disorders;
• neurodegenerative and neuromuscular diseases;
• Ashworth spasticity index ≥ 3.

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

Sponsors

Fondazione Salvatore Maugeri

OTHER

Sponsor Role: lead

Responsible Party

Palmira Bernocchi

Researcher, Care Continuity Unit, Fondazione Salvatore Maugeri, Institute of Lumezzane, (Brescia), Italy

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Vanoglio F, Bernocchi P, Mule C, Garofali F, Mora C, Taveggia G, Scalvini S, Luisa A. Feasibility and efficacy of a robotic device for hand rehabilitation in hemiplegic stroke patients: a randomized pilot controlled study. Clin Rehabil. 2017 Mar;31(3):351-360. doi: 10.1177/0269215516642606. Epub 2016 Jul 10.

Reference Type: RESULT

PMID: 27056250 (View on PubMed)

Other Identifiers

1

Identifier Type: -

Identifier Source: org_study_id