NCT06701370

Brief Summary

The aim of our study was to investigate the effects of task-oriented training added to conventional rehabilitation on upper extremity muscle thickness and upper extremity motor functions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2024

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2024

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

November 20, 2024

Last Update Submit

September 16, 2025

Conditions

Keywords

task oriented training, stroke, exercise, upper extremity

Outcome Measures

Primary Outcomes (3)

  • Fugl Meyer Upper extremity assessment

    It is a disease-specific, objective motor impairment scale designed especially for the evaluation of recovery in hemiplegic patients after stroke. It includes subsections evaluating joint movements, coordination and reflex activities related to the shoulder, elbow, forearm, wrist and hand. The highest score that can be obtained from this assessment is 66. The assessment is applied to the affected upper extremities of individuals in the sitting position. The evaluated joint movements are scored as 0: no movement, 1: partial movement and 2: normal movement. Reflex activity is assessed using a reflex hammer and scored as 0: no reflex activity, 2: reflex activity can be elicited.

    5 minutes

  • Wolf Motor Function Scale

    It is an assessment method developed to evaluate motor skills and used in patients with moderate to severe upper extremity motor deficits. The original version was developed by Wolf et al. The modified version was used in our study and the validity and internal consistency of the WMFT have been proven. The test includes 17 activities. For 15 of the 17 activities, data are collected in two areas: "Functional Skill" and 'Performance Time". The other 2 activities evaluating muscle strength were not used in our study. The duration of the test is 30-45 minutes. Each activity was scored by the physiotherapist on a 0-5 point scale (0= Never used the affected hand during the activity, 5= Normal movement) using the "Functional skill scale". An average score should be calculated for the functional skills scale. Accordingly, the patient can score between 0-5 points in this evaluation and a high score indicates good functional skills. "Performance Time" is recorded in seconds. The

    5 minutes

  • Examination of muscle thickness by ultrasound

    Muscle thickness of the biceps, triceps and anterior deltoid muscles on the hemiplegic and intact side will be measured and recorded by ultrosound before and after treatment.

    10 minutes

Secondary Outcomes (4)

  • Motor Activity Log-28

    5 minutes

  • 2 minutes walking test

    5 minutes

  • Grip strength

    3 minutes

  • Functional Independence Measurements

    10 minutes

Study Arms (2)

Task oriented Training Group

EXPERIMENTAL

Conventional rehabilitation + Upper arm Ergometer \+ Task oriented Training

Other: Task Oriented TrainingOther: Conventional RehabilitationOther: Upper arm ergometer

Conventional Rehabilitation Group

ACTIVE COMPARATOR

Conventional rehabilitation + Upper arm Ergometer

Other: Conventional RehabilitationOther: Upper arm ergometer

Interventions

Task oriented training consists of opening the bottlecap, stacking cubes on different sizes, buttoning,screwing, wearing a coat.

Task oriented Training Group

Bobath weightbearing and mobility exercises for upper extremity and 15 minutes Neuromuscular Electrical Stimulation.

Conventional Rehabilitation GroupTask oriented Training Group

The patients will be rode 5 minutes forwardly and 5 minutes backwardly

Conventional Rehabilitation GroupTask oriented Training Group

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of cerebrovascular accident at least 6 months ago;
  • Score at least 20 points on the mini mental test;
  • Not having pain with tension or severe weakness in the shoulder muscles;
  • Active shoulder flexion movement of at least 30 degrees
  • Having a stroke for the first time
  • The level of motor function is Stage 3 or Stage 4 in Brunnstrom Staging according to the proximal function of the upper extremity
  • Not receiving botulinum toxin treatment for the last 3 months

You may not qualify if:

  • Presence of concomitant neurological, orthopedic, cardiovascular diseases and severe comorbidities
  • Severe spasticity of the elbow flexors more than 2 on the Modified Ashworth Scale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • Chang JJ, Tung WL, Wu WL, Su FC. Effect of bilateral reaching on affected arm motor control in stroke--with and without loading on unaffected arm. Disabil Rehabil. 2006 Dec 30;28(24):1507-16. doi: 10.1080/09638280600646060.

  • Yoo DH, Kim SY. Effects of upper limb robot-assisted therapy in the rehabilitation of stroke patients. J Phys Ther Sci. 2015 Mar;27(3):677-9. doi: 10.1589/jpts.27.677. Epub 2015 Mar 31.

  • Michaelsen SM, Dannenbaum R, Levin MF. Task-specific training with trunk restraint on arm recovery in stroke: randomized control trial. Stroke. 2006 Jan;37(1):186-92. doi: 10.1161/01.STR.0000196940.20446.c9. Epub 2005 Dec 8.

MeSH Terms

Conditions

StrokeMotor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist.Prof.Dr.

Study Record Dates

First Submitted

November 20, 2024

First Posted

November 22, 2024

Study Start

October 30, 2024

Primary Completion

December 15, 2024

Study Completion

March 30, 2025

Last Updated

September 17, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

We share it in order to contribute to future studies.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
september 30- march 30

Locations