Efficacy of Robot-Assisted Rehabilitation of Hand Paralysis After Stroke

Stroke Clinical Trial

Official title:

Efficacy of Short-Term Robot-Assisted Rehabilitation in Patients With Hand Paralysis After Stroke: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02711787
• Other study ID #: Project Code:RC-2015-Gloreha
• Status: Completed
• Phase: N/A
• First received: March 5, 2016
• Last updated: March 11, 2016
• Start date: July 2014
• Est. completion date: June 2015

Study information

• Verified date: March 2016
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Paralysis
• Stroke

Intervention

Device:
• Experimental group
Robotic assisted passive mobilization (Gloreha, Idrogenet, Italy) and traditional rehabilitation.
• Control group
Physiotherapy and occupational therapy.
• traditional rehabilitation
Assisted stretching, shoulder and arm exercises, and functional reaching tasks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from National Institutes of Health Stroke Scale (NIHSS)		baseline, immediately post-intervention (3 weeks).	Yes
Secondary	Change from Visual analogue scale (VAS)		baseline, immediately post-intervention (3 weeks).	Yes
Secondary	Change from Barthel Index (BI)		baseline, immediately post-intervention (3 weeks).	Yes
Secondary	Change from Modified Ashworth Scale (MAS)		baseline, immediately post-intervention	Yes
Secondary	Change from Disabilities of the Arm, Shoulder and Hand (quickDASH)		baseline, immediately post-intervention (3 weeks).	Yes