NCT05526612

Brief Summary

The aim of the study is to compare the effects of specific functional task-oriented motor imagery training combined with the Bobath Therapeutic Approach and physical practice after imagery on upper extremity motor function in stroke patients.

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
32

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable stroke

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 13, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2022

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 31, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 2, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

1 month

First QC Date

August 31, 2022

Last Update Submit

September 2, 2022

Conditions

Keywords

StrokeMotor imageryPhysical practiceBobath therapeutic approach

Outcome Measures

Primary Outcomes (4)

  • The Fugl-Meyer Upper Extremity Scale (FMUE)

    Fugl-Meyer upper extremity (FMUE) Scale scores is an index to assess the sensorimotor impairment in individuals who had stroke. The motor section score ranges from 0 to 66, and the score related to exteroceptive and proprioceptive sensitivity ranges from 0 to 12. The lowest and highest scores correspond to worse and better function.

    The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation

  • Time in minutes to perform a motor task

    The video will be recorded while the patient is performing the eating activity.

    The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation

  • The Motor Activity Log-28 (MAL-28)

    Motor Activity Log is developed to determine the frequency and quality of use of the affected arm It consists of two scales that question how often the affected side's upper extremity is used for each activity during the 28-day activity (Usage Quantity Scale) and how well it can perform the activity if it uses it. On both scales, the patient scores between 0-5. The score that can be obtained is between 0-5 points and the high score indicates good frequency of use and good quality of movement.

    The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation

  • Wolf Motor Function Test (WMFT)

    The Wolf Motor Function Test (WMFT) quantifies upper extremity (UE) motor ability through timed and functional tasks. When administering the WMFT, the examiner should test the less-affected UE followed by the most affected side. Items should be performed as quickly as possible; a maximum of 120 second per task is allowed . The first 6 items involve timed functional tasks, items 7-14 are measures of strength, and the remaining 9 items consist of analyzing movement quality when completing various tasks.

    The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation

Secondary Outcomes (5)

  • Demographic Characteristic of Participants

    1 week before the first treatment session

  • Assessment of Quality of Life

    The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation

  • The Brunnstrom Stages

    Baseline

  • Spasticity Evaluation

    Baseline

  • The Kinesthetic and Visual Imagery Questionnaire (KVIQ)

    The first assessment was evaluated at baseline and the second assessment evaluated change after 8 weeks of rehabilitation

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Motor imagery and Bobath Therapeutic Approach (BTA+MI)

Other: Group 1 Motor imagery and Bobath Therapeutic Approach (BTA+MI)

Group 2

EXPERIMENTAL

Motor imagery, Bobath Therapeutic Approach and Physical practice (BTA+MI+PP)

Other: Group 2 Motor imagery, Bobath Therapeutic Approach and Physical practice (BTA+MI+PP)

Interventions

Motor imagery (MI) is the mental rehearsal of motor abilities to improve function. Without revealing any movement in the body, the representation of the movement is created in the mind, the person imagines that he/she is performing the movement. Eating activity will be applied in motor imagery. Individualized therapy sessions in the Bobath Therapeutic Approach will also be received by the Physiotherapist along with Motor imagery. 2 days a week, 30 minutes session will be applied for a total of 8 weeks.

Group 1

Individualized therapy sessions in the Bobath Therapeutic Approach with motor imagery will be performed by the physiotherapist, and in addition to these, 5 repetitions of the eating activity used in motor imagery will be practiced. 2 days a week, 30 minutes session will be applied for a total of 8 weeks.

Group 2

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A maximum of 24 months have passed since the stroke,
  • Unilateral involvement,
  • Getting a score of 21 and above in the Mini Mental Test,
  • Getting a score of 22 and above in the Fugl-Meyer Test,
  • Ability to understand and follow simple verbal commands,
  • Stage 4 or 5 according to Brunnstrom Upper Extremity Stages,
  • Spasticity 1 or 1+ according to the Modified Ashworth Scale,
  • Having signed the Informed Consent Form.

You may not qualify if:

  • Patients with visual and hearing impairments that would interfere with work.
  • Having pain and limitation of joint movement that may prevent performing the given tasks.
  • Having any neurological disorder other than stroke.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment (Outcomes Assessor)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator,Physical Therapist

Study Record Dates

First Submitted

August 31, 2022

First Posted

September 2, 2022

Study Start

July 13, 2022

Primary Completion

August 13, 2022

Study Completion

January 1, 2023

Last Updated

September 7, 2022

Record last verified: 2022-09

Locations