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NCT Number: NCT02711787

Efficacy of Robot-Assisted Rehabilitation of Hand Paralysis After Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Experimental Group

Device

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

Control group

Device

Physiotherapy and occupational therapy.

traditional rehabilitation

Device

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

Primary outcomes

  1. Change from National Institutes of Health Stroke Scale (NIHSS)

    Time frame: baseline, immediately post-intervention (3 weeks).

Secondary outcomes

  1. Change from Visual analogue scale (VAS)

    Time frame: baseline, immediately post-intervention (3 weeks).

  2. Change from Barthel Index (BI)

    Time frame: baseline, immediately post-intervention (3 weeks).

  3. Change from Modified Ashworth Scale (MAS)

    Time frame: baseline, immediately post-intervention

  4. Change from Disabilities of the Arm, Shoulder and Hand (quickDASH)

    Time frame: baseline, immediately post-intervention (3 weeks).

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 17, 2016
Registry last updated
Mar 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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