Efficacy of Robot-Assisted Rehabilitation of Hand Paralysis After Stroke

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02711787

Enrollment

Registered

2016-03-17

Start date

2014-07-31

Completion date

2015-06-30

Last updated

2016-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Hand, Paralysis, Stroke

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).

Interventions

DEVICEExperimental group

Robotic assisted passive mobilization (Gloreha, Idrogenet, Italy) and traditional rehabilitation.

DEVICEControl group

Physiotherapy and occupational therapy.

DEVICEtraditional rehabilitation

Assisted stretching, shoulder and arm exercises, and functional reaching tasks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to 90 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
Change from National Institutes of Health Stroke Scale (NIHSS)	baseline, immediately post-intervention (3 weeks).

Secondary

Measure	Time frame
Change from Visual analogue scale (VAS)	baseline, immediately post-intervention (3 weeks).
Change from Barthel Index (BI)	baseline, immediately post-intervention (3 weeks).
Change from Modified Ashworth Scale (MAS)	baseline, immediately post-intervention
Change from Disabilities of the Arm, Shoulder and Hand (quickDASH)	baseline, immediately post-intervention (3 weeks).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026