Efficacy of Robot-Assisted Rehabilitation of Hand Paralysis After Stroke

Don Carlo Gnocchi Onlus Foundation

Status: Completed

Conditions: Stroke

Treatments: Device: traditional rehabilitation; Device: Control group; Device: Experimental group

Study type: Interventional

Funder types: Other

Identifiers

NCT02711787

Project Code:RC-2015-Gloreha

Details and patient eligibility

About

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.

Full 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).

Enrollment: 32 patients

Sex: All

Ages: 50 to 90 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

32 participants in 2 patient groups

Experimental group

Experimental group

Description:

Robotic device Gloreha (Gloreha, Idrogenet, Italy) and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week).

Treatment:

Device: traditional rehabilitation

Device: Experimental group

Control group

Active Comparator group

Description:

Physiotherapy, occupational therapy and traditional rehabilitation, 60-minute session for 3 consecutive weeks (3 days/week).

Treatment:

Device: traditional rehabilitation

Device: Control group