NCT03175237

Brief Summary

To evaluate the benefits of Mirror Therapy (MT) and motivation in patients with different levels of post-stroke motor impairment with two different therapy protocols. This is a randomized uncontrolled blinded study, with 27 individuals in the chronic phase of stroke. Participants were randomized into two intervention groups: MT group with motor patterns of movement (MP, n=13) and MT group with specific functional activities (SA, n=14). Motor impairment assessments (Fugl-Meyer Assessment - FMA), motivation (Intrinsic Motivation Inventory) and functionality (Functional Independence Measure - FIM) were performed before and after treatment, and 3 months after the end of sessions (follow-up). In each intervention group,there were patients classified with mild, moderate or severe motor impairment, according to FMA. All participants performed 15 MT sessions, 3 times a week for 50 minutes each session.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started May 2014

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

May 10, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 5, 2017

Completed
Last Updated

August 8, 2017

Status Verified

August 1, 2017

Enrollment Period

1.3 years

First QC Date

May 20, 2017

Last Update Submit

August 7, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Fugl-Meyer Assessment Scale

    Sensory and motor Impairment in post-stroke subjects. Severity of motor damage. In this case, use only upper limb session (score 66)

    baseline, 8 weeks and 3 months (follow-up)

Secondary Outcomes (4)

  • Mini-mental state examination

    baseline

  • Berg Balance Scale

    baseline

  • Intrinsic Motivation Inventory

    baseline, 7 days and 14 days

  • Functional Independence of measure

    baseline, 8 weeks and 3 months (follow-up)

Study Arms (2)

Group of Motor Patterns

EXPERIMENTAL

For the mirror therapy protocol applied to the Motor Standard, each patient was treated with 15 mirror therapy sessions, 3 times a week for a total duration of 50 minutes. There were 4 exercises of voluntary range of motion involving the extension and mass flexion of the fingers, adduction and abduction of the fingers, pronation and supination of the forearm and elbow extension with associated shoulder elevation.

Other: Mirror Therapy

Group of Functional Activities

EXPERIMENTAL

For the mirror therapy protocol applied to functional activities, four functional exercises were performed: fitting of pieces stimulating fine and thick gripping, stacking of cubes / cups and transfer of objects of different shapes and sizes. Each patient was treated with 15 mirror therapy sessions, 3 times a week with a total duration of 50 minutes

Other: Mirror Therapy

Interventions

Group of Functional ActivitiesGroup of Motor Patterns

Eligibility Criteria

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

You may not qualify if:

  • Those with other neurological diseases and associated physical or mental disabilities, stroke trauma, pain and joint contractures in the upper limb that prevented movement and the ones who missed therapy more than 3 times in a row were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Study Officials

  • Roberta O Cacho, PhD

    Universidade Federal do Rio Grande do Norte

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Roberta de Oliveira Cacho

Study Record Dates

First Submitted

May 20, 2017

First Posted

June 5, 2017

Study Start

May 10, 2014

Primary Completion

August 15, 2015

Study Completion

September 30, 2015

Last Updated

August 8, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share