NCT06196411

Brief Summary

The aim of the randomized controlled study is to investigate the effects of task-oriented training on motor and cognitive functions combined with Bobath training in patients with stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Dec 2023

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 24, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 25, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2024

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 18, 2024

Completed
Last Updated

July 8, 2024

Status Verified

July 1, 2024

Enrollment Period

2 months

First QC Date

December 25, 2023

Last Update Submit

July 4, 2024

Conditions

Keywords

StrokeTask-oriented trainingBobath trainingMotor functionsCognitive functions

Outcome Measures

Primary Outcomes (4)

  • Mini Mental State Examination (MMSE)

    The Mini Mental State Examination will be used for evaluating cognitive functions.

    8 weeks

  • Dynamic Loewenstein Occupational Therapy Cognitive Assessment- Geriatric Version (DLOTCA-G)

    DLOTCA-G is a battery test with a test booklet and test kits including 28 items in seven cognitive domains which are orientation, awareness, spatial perception, visuomotor construction, visual perception, praxis and thinking operations.

    8 weeks

  • Functional Independence Measure (FIM)

    FIM will be used to assess and rate motor and cognitive functional status in patients with stroke.

    8 weeks

  • Barthel Index (BI)

    BI will be used to assess motor functions.

    8 weeks

Study Arms (2)

Study Group

EXPERIMENTAL

Task-oriented Training Bobath Training

Behavioral: Task-oriented TrainingBehavioral: Bobath Training

Control Group

ACTIVE COMPARATOR

Bobath Training

Behavioral: Bobath Training

Interventions

Task-oriented training will be applied to study group 5 days a week, for a total of 6 weeks, in addition to Bobath training. Task-oriented training will consist of performing the lying, sitting, standing and walking exercises by performing tasks for specific goals. Exercises will be perform by accomplishing tasks such as touching the ball with the upper or lower extremities, reaching for the ball, crossing various tracks to move blocks from one place to another, walking through obstacles or climbing stairs.

Study Group
Bobath TrainingBEHAVIORAL

Bobath Concept includes sensory, perceptual and adaptive exercises aimed at improving function through mobilisation, weight-bearing, practicing more normal movement patterns and performing more efficient, less effortful tasks.

Control GroupStudy Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteering to participate in the study
  • Be in the age range of 18-80 years
  • Clinical diagnosis of hemiplegia following stroke
  • Time since stroke between 2 and 8 weeks
  • Having stable vital signs
  • A score between 18-23 on the Mini Mental State Examination (MMSE)

You may not qualify if:

  • Having global aphasia and/or severe apraxia
  • Diagnosis of dementia or Alzheimer's prior to stroke
  • Participants who discontinued treatment
  • Receiving rehabilitation service before

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eksen Sağlık Inpatient Physical Therapy and Rehabilitation Center

Istanbul, Ataşehir, 34746, 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
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 25, 2023

First Posted

January 9, 2024

Study Start

December 24, 2023

Primary Completion

February 19, 2024

Study Completion

March 18, 2024

Last Updated

July 8, 2024

Record last verified: 2024-07

Locations