N/A
N=30
Feasibility and Efficacy of a Robotic Device for Hand Rehabilitation
Stroke · Upper Extremity Hemiplegia · Disorder of Hand
Bottom Line
View on ClinicalTrials.gov: NCT02628418 ↗Enrolled (actual)
30
Serious AEs
10.0%
Results posted
Aug 2016
Primary outcome: Primary: Number of Patients Who Completed the Hand Rehabilitation Program — 14; 13 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- General Rehabilitation (Other); Specific hand rehabilitation by Gloreha device (Device); Specific hand rehabilitation performed by physiotherapist (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fondazione Salvatore Maugeri
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Completed the Hand Rehabilitation Program |
14; 13 | — |
| PRIMARY Side Effects Using Gloreha Device |
0; 0 | — |
| PRIMARY Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Motricity Index at End of Inpatient Rehabilitation |
23.0; 5.2 | — |
| PRIMARY Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Nine Hole Peg Test at End of Inpatient Rehabilitation. |
0.16; 0.02 | — |
| SECONDARY The Feasibility of This New Neuromotor Rehabilitation Device (Gloreha) |
3.15 | — |
| SECONDARY Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Grip Test at End of Inpatient Rehabilitation. |
0.27; 0.03 | — |
| SECONDARY Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Pinch Test at End of Inpatient Rehabilitation. |
0.07; 0.02 | — |
| SECONDARY Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Quick-DASH Questionnaire at End of Inpatient Rehabilitation. |
-15.7; -0.43 | — |
| SECONDARY The Costs Involved in Using Gloreha in the Rehabilitation |
237; 480 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02628418). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.