NCT02776306

Brief Summary

The purpose of this study is to evaluate the effects of mirror box therapy on upper extremity, motor recovery and motor functioning in patients that have suffered a stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable stroke

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

Study Start

First participant enrolled

April 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 18, 2016

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

6 years

First QC Date

April 7, 2016

Last Update Submit

May 30, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in brain connectivity will be assessed by resting-state fMRI

    Baseline, 3 weeks and at 6 weeks

Secondary Outcomes (4)

  • Activity of daily living will be assessed with Barthel index.

    Baseline, 3 weeks and at 6 weeks

  • Function of the affected hemiplegic upper limb will be assessed with action research arm test

    Baseline, 3 weeks and at 6 weeks

  • Impairment in the hemiplegic upper limb will be assessed with Fugl Meyer test.

    Baseline, 3 weeks and at 6 weeks

  • Grip strength will be assessed using hand dynamometer

    Baseline, 3 weeks and at 6 weeks

Study Arms (2)

Mirror box therapy

EXPERIMENTAL

The participants in the mirror box therapy arm will receive mirror box therapy for 3 weeks for upper limb rehabilitation post stroke.

Other: Mirror Box therapy

Standard treatment group

NO INTERVENTION

The participants will receive the standard treatment arm for 3 weeks for upper limb rehabilitation post stroke.

Interventions

In mirror box therapy the patient uses the reflection of their good arm to trick to brain into thinking that the effected arm is working.

Mirror box therapy

Eligibility Criteria

Age18 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • yrs to 105yrs
  • Hemiparetic upper limb post stroke
  • Capable of providing informed consent
  • Intact vision: if diagnosis of peripheral field defect, patient should be able to compensate for it.

You may not qualify if:

  • Any contraindication to MRI scanning
  • Clinically significant psychiatric disorder (e.g. depression)
  • Pre-existing neurological or psychiatric disease that could confound the study results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southend Hospital

Westcliff-on-Sea, Essex, SS0 0RY, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Iris Grunwald

    Anglia Ruskin University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2016

First Posted

May 18, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

June 1, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations