NCT05423119

Brief Summary

Clinical predictors of rehabilitation-induced arm recovery after stroke are still missing since literature provides evidence mainly on the spontaneous recovery path. This longitudinal cohort study aims to identify neurophysiological and behavioural features able to predict arm recovery and how it can change according to provided rehabilitation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 19, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

2.5 years

First QC Date

June 10, 2022

Last Update Submit

September 28, 2023

Conditions

Keywords

rehabilitationupper limbprognosisneurophysiology

Outcome Measures

Primary Outcomes (1)

  • Fugl-Meyer Assessment

    Fugl-Meyer Upper Extremity is a stroke-specific scale which assesses the upper limb motor functioning in patients with post-stroke hemiplegia. There are 3 values: 0 (severe impairment), 1 (moderate impairment), 2 (preserved function). The minimum value is 0 points, which corresponds to upper limb hemiplegia. The maximum value is 66 points, which corresponds to normal motor performance.

    Change from baseline up to 8 weeks.

Secondary Outcomes (8)

  • Action Research Arm Test

    Change from baseline up to 8 weeks.

  • Reaching Performance Scale

    Change from baseline up to 8 weeks.

  • Box & Blocks Test

    Change from baseline up to 8 weeks.

  • Medical Research Council

    Change from baseline up to 8 weeks.

  • Imaging data

    Change from baseline up to 8 weeks.

  • +3 more secondary outcomes

Interventions

upper limb rehabilitation with and without technologies

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stroke patients undergoing upper limb rehabilitation

You may qualify if:

  • first ever single stroke
  • unilateral cortical/subcortical stroke

You may not qualify if:

  • other neurological disease
  • psychiatric disorders
  • cerebellar stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCSSanCamillo

Lido, Venezia, 30126, Italy

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Nicola Filippiin

    IRCCS San Camillo, Venezia, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD, Psychologist

Study Record Dates

First Submitted

June 10, 2022

First Posted

June 21, 2022

Study Start

August 19, 2021

Primary Completion

February 28, 2024

Study Completion

February 28, 2024

Last Updated

September 29, 2023

Record last verified: 2023-09

Locations