NCT06272175

Brief Summary

Stroke is a sudden disruption of blood flow to the brain, resulting in physical and mental disabilities. It's a global health issue affecting millions each year, often leading to paralysis, altered muscle tone, and loss of motor control and balance. This study aims to examine the immediate effects of open and closed kinetic chain activites on upper extremity spasticity and motor dexterity in hemiplegic patients. This study will be conducted simultaneously at İstinye University Hospital Medical Park Gaziosmanpaşa and İstinye University Physiotherapy and Rehabilitation Application and Research Center (İSÜFİZYOTEM). 50 stroke patients will be included in the study, and all participants will be asked to sign an informed consent form. At the beginning of the session, all participants will be evaluated for their socio-demographic characteristics by a questionnaire created by the researchers, muscle viscoelastic properties by MyotonPRO, upper extremity muscle tone by Modified Ashworth Scale, upper extremity motor dexterity by Box and Block Test, and upper extremity joint range of motion by goniometer and by a phone application named as PhysioMaster. After the assessment, participants will be randomly assigned to two groups: open kinetic chain activity group and closed kinetic chain activity group. After performing the exercises, all evaluations will be conducted again. Thus, the aim is to understand the immediate effects of two different group exercises on the evaluated parameters.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Mar 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

February 15, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 22, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

March 4, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

April 16, 2025

Status Verified

April 1, 2025

Enrollment Period

1.6 years

First QC Date

February 15, 2024

Last Update Submit

April 11, 2025

Conditions

Keywords

StrokeSpasticityDexterityOpen Kinetic ChainClosed Kinetic Chain

Outcome Measures

Primary Outcomes (2)

  • MyotonPRO digital palpation device

    This device is a patented, certified, digital measurement device that measures the amount of tissue displacement that occurs per unit force applied by a probe pressed perpendicularly to the skin overlying the muscle. It measures the viscoelastic properties of the muscles. Latissimus Dorsi will be measured from a point 5 cm above the lower corner of the scapula with the shoulder in 80 flexion. Pectoralis Major will be measured three-quarters of the way from the line between the sternum and the nodule prominence. Measurement of the Biceps Brachii and Brachioradialis muscles will be made from the most swollen points of the muscles. For measurement of the Flexor Carpi Radialis muscle, patients will be taken supine, with the forearm supinated and the elbow approximately 40 degrees flexed, at the one-third (approximately) point of the distance between the elbow line and the lateral side of the ulnar styloid. All measurements will be repeated 3 times and the average will be calculated.

    6 minutes

  • Box and Block Test

    It is a standardized assessment used to measure upper extremity motor dexterity. It involves moving blocks from one side of a box to the other within a minute. It is a clinic-friendly standardized assessment that is portable, easy to obtain, simple to administer, and can be administered quickly without a specific setting.

    1 minute

Secondary Outcomes (3)

  • Modified Ashworth Scale

    3 minutes

  • Goniometer

    5 minutes

  • PhysioMaster

    5 minutes

Study Arms (2)

Open Kinetic Chain Activity Group

EXPERIMENTAL

Open kinetic chain activity will involve Flexion-Abduction-External Rotation and Flexion-Adduction-External Rotation patterns from the Proprioceptive Neuromuscular Facilitation (PNF). During the application, participants will lie on their back, and the pattern will be initiated from the opposite direction of the targeted movement. Participants will be encouraged to perform the movement as actively as possible. Assistance will be provided if the participant cannot complete the pattern. No other PNF techniques will be applied. Both patterns will be practiced for 10 repetitions. Resting periods will be provided as needed to prevent fatigue. The entire application is planned to last approximately 5 minutes.

Other: Open Kinetic Chain Activity

Closed Kinetic Chain Activity Group

EXPERIMENTAL

For closed kinetic chain activity of the upper extremity, an activity involving weight shifting onto the hands on a table while standing with the elbows in extension will be used. Participants will be asked to shift weight onto the hemiplegic upper extremity for 30 seconds. After a 30-second rest period, the weight shifting will be repeated for a second time.

Other: Closed Kinetic Chain Activity

Interventions

PNF Flexion-Abduction-External Rotation and Flexion-Adduction-External Rotation patterns will be actively performed on the hemiplegic upper extremity.

Open Kinetic Chain Activity Group

Weight-bearing on the hemiplegic hand with extended elbow in standing position

Closed Kinetic Chain Activity Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stroke diagnosis;
  • Hemiplegia;
  • Subacute\&chronic phase (more than 3 months);
  • Brunnstrom 3-4-5;
  • Unsupported sitting ability;
  • Being volunteer.

You may not qualify if:

  • Having Botox within the last 6 months;
  • according to Modified Ashworth Scale;
  • Other neurological diagnosis other than stroke.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University Hospital Medical Park Gaziosmanpasa

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

StrokeMuscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Merve Can

    Istinye University

    STUDY CHAIR
  • Seyhan Söyüncü

    Istinye University

    STUDY CHAIR

Central Study Contacts

Çiçek GÜNDAY, PhD(c)

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 15, 2024

First Posted

February 22, 2024

Study Start

March 4, 2024

Primary Completion

September 30, 2025

Study Completion

December 30, 2025

Last Updated

April 16, 2025

Record last verified: 2025-04

Locations