NCT02711787

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable stroke

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
Last Updated

March 17, 2016

Status Verified

March 1, 2016

Enrollment Period

7 months

First QC Date

March 5, 2016

Last Update Submit

March 11, 2016

Conditions

Stroke

Keywords

HandParalysisStroke

Outcome Measures

Primary Outcomes (1)

  • Change from National Institutes of Health Stroke Scale (NIHSS)

    baseline, immediately post-intervention (3 weeks).

Secondary Outcomes (4)

  • 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).

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Device: Experimental groupDevice: traditional rehabilitation

Control group

ACTIVE COMPARATOR

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

Device: Control groupDevice: traditional rehabilitation

Interventions

Experimental groupDEVICE

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

Experimental group
Control groupDEVICE

Physiotherapy and occupational therapy.

Control group
traditional rehabilitationDEVICE

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

Control groupExperimental group

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

StrokeParalysis

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • JORGE H VILLAFAÑE, PhD

    IRCCS Don Gnocchi Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

March 5, 2016

First Posted

March 17, 2016

Study Start

July 1, 2014

Primary Completion

February 1, 2015

Study Completion

June 1, 2015

Last Updated

March 17, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share