NCT03655327

Brief Summary

A cross-sectional study of Reach-to-Grasp (RTG) movement of the upper limb of stroke patients vs. healthy controls. 30 stroke patients and 30 healthy controls will take place in a cross-sectional study. 3D kinematics and force regulation measures of RTG to a full and an empty cup at three different table heights will be measured. Motion analysis will include joint position and inter-limb coordination, velocity, and smoothness of movement. Data collected from the force sensor embaded in the cup will include peak force, time to peak force and variability in force production.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

July 12, 2019

Status Verified

July 1, 2019

Enrollment Period

1.4 years

First QC Date

August 30, 2018

Last Update Submit

July 11, 2019

Conditions

Keywords

stroke rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Index of curvature

    the ratio between a straight line and the path of the movement the participant did

    30 minutes

Study Arms (2)

stroke patients

stroke patients with upper limb paresis

Other: reach to grasp a cup

healthy control group

healthy participants with no motor disability of the upper limb

Other: reach to grasp a cup

Interventions

reach to grasp a cup of different weights located at different heights of table

healthy control groupstroke patients

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

group 1: stroke patients with upper limb paresis group 2: healthy controls

You may qualify if:

  • First unilateral (ischemic or hemorrhagic) stroke with diagnosis confirmed by imaging from hospital discharge records.
  • Age 30-85 years.
  • Mini-Mental State Examination score ≥ 24/30.
  • Fugl-Meyer Upper Extremity score 16-66.
  • Pain level ≤ 4 on a 10-point Visual Analogue Scale.
  • Upper limb muscle tone assessed by Modified Ashworth Scale ≤ 2
  • Brunnstrom stages of motor recovery ≥ 3/7
  • Ability to sit independently without external support.

You may not qualify if:

  • Additional neurological problems (such us Parkinson's disease, unilateral neglect, pusher syndrome and apraxia).
  • Musculoskeletal, 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)

Beit Hadar Geriatric center

Ashdod, South, Israel

Location

MeSH Terms

Conditions

Paresis

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ron Milo, MD

    Barzilai Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 30, 2018

First Posted

August 31, 2018

Study Start

August 1, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

July 12, 2019

Record last verified: 2019-07

Locations