Clinical trial NCT02711787: Efficacy of Robot-Assisted Rehabilitation of Hand Paralysis After Stroke
Official title: Efficacy of Short-Term Robot-Assisted Rehabilitation in Patients With Hand Paralysis After Stroke: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Hand
Paralysis
Stroke
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 32
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Among robotic devices, Gloreha, with its compliant mechanical transmission, may represent an easily applied innovative solution to rehabilitation, because the hand can perform grasp and release activities wearing the device by mean of a flexible and light orthosis. Our objective on this research was to the robotic assisted motion and activity in additional to physiotherapy (PT) and occupational therapy (OT), on stroke patients with hand paralysis.

Detailed description: The investigators evaluated the effectiveness of a robotic-assisted motion and activity in additional to physiotherapy (PT) and occupational therapy (OT), on stroke patients with hand paralysis. A randomized controlled trial. The experimental group received a passive mobilization of the hand through the robotic device Gloreha and control group received a PT and OT for 3 consecutive weeks (3 days/week) in addition to traditional rehabilitation. Outcomes included the National Institutes of Health Stroke Scale (NIHSS), Modified Ashworth Scale (MAS), Barthel index (BI), Motricity index (MI), short version of the Disabilities of the Arm, Shoulder and Hand (quickDASH), and the Visual Analogue Scale (VAS) measurements. All measures were collected at baseline and end of the intervention (3 weeks).

Eligibility criteria: Inclusion Criteria:

* acute phase of stroke
* first stroke episode.
* no history of peripheral nerve injury or musculoskeletal disease
* no contracture of the affected wrist or fingers (Modified Ashworth\<3)
* no history of any invasive procedure (Botulinum toxin type A) for the treatment of spasticity for at least 6 months prior to the start of this study.
* paralysis of the wrist and fingers

Exclusion Criteria:

* unstable medical disorders, active Complex Regional Pain Syndrome (CRPS) severe spatial neglect, aphasia, or cognitive problems.
* scored greater than 4 points on the Beck Depression Inventory (BDI)
* more than 30 points in the State Trait Anxiety Inventory (STAI)

Primary outcomes:
measure: Change from National Institutes of Health Stroke Scale (NIHSS)
timeFrame: baseline, immediately post-intervention (3 weeks).
Secondary outcomes:
measure: Change from Visual analogue scale (VAS)
timeFrame: baseline, immediately post-intervention (3 weeks).
measure: Change from Barthel Index (BI)
timeFrame: baseline, immediately post-intervention (3 weeks).
measure: Change from Modified Ashworth Scale (MAS)
timeFrame: baseline, immediately post-intervention
measure: Change from Disabilities of the Arm, Shoulder and Hand (quickDASH)
timeFrame: baseline, immediately post-intervention (3 weeks).
Other outcomes:
Locations:
Study officials:
affiliation: IRCCS Don Gnocchi Foundation
name: JORGE H VILLAFAÑE, PhD
role: PRINCIPAL_INVESTIGATOR
References: