Effects of Flexion and Extension Type Arm Slings on Walking Kinematics and Balance in Stroke Patients

NCT07036900 | Recruiting

• 1 other identifier: ODGQzpAt
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

In the clinic, stroke patients are seen to use flexor or extensor type arm slings, but no study was found investigating the effects of these different types of arm slings on walking kinematics and balance. The aim of the presented study was to investigate the effects of different types of arm slings on walking kinematics and balance in stroke patients and to compare them with healthy individuals.

Conditions

Stroke

Keywords

Arm Slings; Walking Kinematics; Balance; Stroke

Outcome Measures

Primary Outcomes (2)

• PABLO ® Lower Extremity inertial sensor

  Inertial measurement unit (IMU) systems have been validated for measuring joint angles and temporal characteristics during lower extremity movements (O'Reilly et al., 2018). Gait parameters, such as stance and swing phase durations, step length, walking speed, and cadence, can be determined using two inertial sensors placed in the shoes. Each shoe is equipped with a PABLO Lower Extremity Inertial Sensor. The sensors measure angular velocity and acceleration at a sampling frequency of 110Hz. Each sensor transmits data via Bluetooth. The sensors are attached to the participants' shoes using custom Velcro straps. It has been found that inertial measurement unit systems work reliably not only in healthy individuals but also in patients, providing accurate results under different pathological gait patterns (Laidig et al., 2021). In our study, gait analysis was conducted to establish reference values by evaluating stroke patients and healthy individuals of the same age.

  8 min.

• TYMO ® Balance Plate

  The TYMO® Balance Plate (Tyromotion, Austria) is a standardized balance analysis device used to assess posture and balance in an upright stance. The TYMO® force sensors detect weight shifting and measure the center of pressure, body sway, and load balance on the feet. These data provide indicators of balance, stability, and symmetry. The TYMO® system is a versatile and easy-to-use assessment and treatment tool consisting of the TYMO Therapy Board and software. Participants are required to stand on a platform for 30 seconds and undergo four test positions: 1) feet apart, eyes open, firm support surface; 2) feet apart, eyes closed, firm support surface; 3) feet apart, eyes open, soft support surface/foam; 4) feet apart, eyes closed, soft support surface/foam. Each position was tested once, and the displacement of the center of body mass was measured in centimeters (Dudoniene et al., 2023).

  8-10 min.

Secondary Outcomes (1)

• Timed Up and Go Test

  3-5 min.

Study Arms (2)

Stroke patients (experimental group (EG))

All test assesments were explained to the patient both verbally and visually. All assesments were applied for patients and healthy participants on the same day. Patients using assistive devices were assessed with these devices. Participants were initially assessed for gait analysis without an arm sling. Then, assessments were conducted by applying a flexor arm sling first, followed by an extensor arm sling. The assessments and data collection were conducted by physiotherapists.

Healthy individuals (control group (CG))

All test assesments were explained to the patient both verbally and visually. All assesments were applied for patients and healthy participants on the same day. Patients using assistive devices were assessed with these devices. Participants were initially assessed for gait analysis without an arm sling. Then, assessments were conducted by applying a flexor arm sling first, followed by an extensor arm sling. The assessments and data collection were conducted by physiotherapists.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This prospective, randomized controlled study involved ambulatory stroke patients (experimental group (EG)) and healthy individuals (control group (CG)).

You may not qualify if:

• (1) severe visual impairments, (2) cerebellar involvement, (3) upper extremity Brunnstrom stage ≤ 3, (4) cancer diagnosis, (5) presence of a neurological or orthopedic condition other than stroke, (6) inability to understand and follow commands or lack of cooperation.

Sponsors & Collaborators

• Ceren Bayrak: lead

Study Sites (1)

Bahçeşehir Liv Hospital Neur-on

Istanbul, Turkey (Türkiye)

RECRUITING

Related Links

• article
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MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Ceren Bayrak Dörtkol, Msc

CONTACT

+905399165286; cerenbayrakdortkol@gmail.com

Tahire Başak Demir, Msc

CONTACT

+905394848542; tahirebasakdemir@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD (c)

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 25, 2025
• Study Start: May 30, 2025
• Primary Completion: December 30, 2025
• Study Completion: April 30, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)