NCT03651063

Brief Summary

30 one year post stroke patients with upper limb paresis will be recruited to this study. The study is an RCT consists of two groups of intervention: 1. social robot, 2. computer, and one control group with no intervention. the intervention consists of 15 therapy sessions of reach-to-grasp games of the affected upper limb.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

August 21, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

May 10, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

November 8, 2021

Status Verified

October 1, 2021

Enrollment Period

2.4 years

First QC Date

August 21, 2018

Last Update Submit

October 30, 2021

Conditions

Upper Extremity Paralysis

Keywords

rehabilitation; social robots

Outcome Measures

Primary Outcomes (2)

  • Sensory Motor Recovery of the upper limb

    upper limb impairment assessment will be assessed by the Fugl-Meyer Assessment. This is the gold-standard assessment for upper limb motor ability in stroke patients. It comprises of 33 items.

    20 minutes

  • The amount of use of the upper extremity in everyday life

    The Motor Activity Log: a questionnaire consist of items regarding the use of the affected arm in every day tasks

    15 minutes

Secondary Outcomes (2)

  • index of curvature

    30 minutes

  • stroke impact scale

    30 minutes

Other Outcomes (1)

  • Perceived Competence (Exercising Regularly) questionnaire

    5 minutes

Study Arms (3)

social robot group

EXPERIMENTAL
Other: social robot

computer group

ACTIVE COMPARATOR
Other: computer group

contro: no intervention

NO INTERVENTION

This group will only be a follow up: clinical examination at the entrance and follow 5 weeks with clinical examination 5 weeks post, with no intervention.

Interventions

social robotOTHER

Reach To Grasp games with a social robot

social robot group
computer groupOTHER

reach to grasp games with a computer screen

computer group

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • First unilateral stroke (ischemic or hemorrhagic)
  • Mini-Mental State Examination (MMSE) score ≥ 24/30
  • Fugl-Meyer Upper Extremity (FM-UE) score 16-66
  • Upper limb muscle tone assessed by Modified Ashworth Scale ≤ 2
  • Ability of the participant to sit independently without external support. -

You may not qualify if:

  • Additional neurological or musculoskeletal problems (such as Parkinson's disease, unilateral neglect, Pusher syndrome and apraxia).
  • Severe vision or sensory deficits affecting upper limb movements.
  • Aphasia affecting understanding of simple instructions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aleh Negev Rehabilitation Center

Ofakim, South, Israel

Location

Related Publications (2)

  • Feingold-Polak R, Barzel O, Levy-Tzedek S. Socially Assistive Robot for Stroke Rehabilitation: A Long-Term in-the-Wild Pilot Randomized Controlled Trial. IEEE Trans Neural Syst Rehabil Eng. 2024;32:1616-1626. doi: 10.1109/TNSRE.2024.3387320. Epub 2024 Apr 19.

    PMID: 38598401DERIVED

  • Feingold-Polak R, Barzel O, Levy-Tzedek S. A robot goes to rehab: a novel gamified system for long-term stroke rehabilitation using a socially assistive robot-methodology and usability testing. J Neuroeng Rehabil. 2021 Jul 28;18(1):122. doi: 10.1186/s12984-021-00915-2.

    PMID: 34321035DERIVED

MeSH Terms

Interventions

Robotics

Intervention Hierarchy (Ancestors)

AutomationTechnologyTechnology, Industry, and Agriculture

Study Officials

  • Shelly Levy-Tzedek, PhD

    Ben-Gurion University of the Negev

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 3 groups, two groups each have a different intervention program, one control group with no intervention, only standard care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 21, 2018

First Posted

August 29, 2018

Study Start

May 10, 2019

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

November 8, 2021

Record last verified: 2021-10

Locations

IL(1)