NCT03191422

Brief Summary

This study aims to explore if the LSVT BIG® - a motor learning based treatment program designed for rehabilitation of people with Parkinson's disease could be beneficial for chronic stroke rehabilitation. A single-case experimental design with two adult participants, will be monitored for performance on self-selected goals before, during and after participating in the treatment program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 4, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 19, 2017

Completed
Last Updated

June 26, 2017

Status Verified

June 1, 2017

Enrollment Period

4 months

First QC Date

June 13, 2017

Last Update Submit

June 23, 2017

Conditions

Keywords

RehabilitationOccupational Performance

Outcome Measures

Primary Outcomes (1)

  • Change in perceived occupational performance

    Positive change on performance score using the Canadian Occupational Performance Measure (COPM)

    Administered weekly, for 6 weeks pre-intervention, 4 weeks during intervention and 5 post-intervention

Secondary Outcomes (3)

  • Perceived changes in upper extremity use

    Administered weekly, for 6 weeks pre-intervention, 4 weeks during intervention and 5 post-intervention

  • Objective rating of activity performance

    Administered at week 1 and week 10

  • Rating of upper extremity function

    Administered at week 1 and week 10

Study Arms (1)

LSVT BIG intervention recipients

EXPERIMENTAL

Participants participated in all of the evaluation steps as well as the LSVT BIG protocol which includes 16, 1-hour intervention sessions with a certified therapist performing, targeted exercises and activities to improve participation in occupations - with a focus on large amplitude movement.

Behavioral: LSVT BIG

Interventions

LSVT BIGBEHAVIORAL

LSVT BIG is a motor learning based intervention 4 hour long sessions per week for 4 weeks following a specific protocol. Each session is composed of exercises and participant specific activities, as well as a homework program.

LSVT BIG intervention recipients

Eligibility Criteria

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

You may qualify if:

  • stroke at least 6 months previously,
  • communication in english or french,
  • adequate cognition to follow direction and complete independent homework,
  • independent mobility,
  • medical stability,
  • minimum Stage 3 for arm and hand on the Cherokee McMaster Stroke Assessment

You may not qualify if:

  • dementia,
  • psychiatric disorder,
  • medical condition that would prevent participation in aerobic exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa

Ottawa, Ontario, Canada

Location

Study Officials

  • Valerie Metcalfe

    University of Ottawa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Outcome Assessor's for 2 of the outcome measures were blinded to the order of the pre and post assessment videos for rating, as well as being unfamiliar with the intervention protocol.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single-Case experimental design One repetition
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's Candidate

Study Record Dates

First Submitted

June 13, 2017

First Posted

June 19, 2017

Study Start

July 4, 2016

Primary Completion

November 14, 2016

Study Completion

November 14, 2016

Last Updated

June 26, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

No plan to share data.

Locations