CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
General Rehabilitation +2 moreother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02628418
NCT02628418N/ACompleted

Feasibility and Efficacy of a Robotic Device for Hand Rehabilitation in Hemiplegic Stroke Patients: a Randomized Pilot Controlled Study

Fondazione Salvatore Maugeri·interventional·Posted Dec 11, 2015·Updated Sep 15, 2016

In Brief

A clinical study evaluating General Rehabilitation, Specific hand rehabilitation by Gloreha device, and 1 other intervention for Stroke and 2 related conditions. Completed, enrolled 30 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 11, 2015
Enrollment StartMay 1, 2013
Primary CompletionMar 1, 2014
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.6 years ago

Interventions

General Rehabilitationother

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 devicedevice

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).

Specific hand rehabilitation performed by physiotherapistother

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).