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Feasibility and Efficacy of a Robotic Device for Hand Rehabilitation

NCT02628418 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-09-15

Study results available
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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.

Conditions

  • Stroke
  • Upper Extremity Hemiplegia
  • Disorder of Hand

Interventions

OTHER

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.

DEVICE

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).

OTHER

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).

Sponsors & Collaborators

  • Fondazione Salvatore Maugeri

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-03-31
Completion
2014-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02628418 on ClinicalTrials.gov