Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07496853

Effect of Upper Extremity Support on Spatiotemporal Parameters of Gait in Individuals With Stroke

Purpose: The primary goal of this study is to investigate how different levels of upper extremity (arm) support affect walking patterns in individuals who have experienced a stroke. Specifically, the research aims to determine how restricting or facilitating arm swing during walking modulates spatiotemporal gait parameters (such as speed, step length, and rhythm).

Background: Arm swing plays a crucial role in maintaining balance, stability, and energy efficiency during normal walking. Following a stroke, many patients use walking aids (like canes or walkers) or clinical supports (like parallel bars) that restrict natural arm movement. This study examines whether these restrictions significantly alter gait mechanics in the stroke population.

Methodology: Participants will participate in a cross-over experimental trial. Each participant will walk on a specialized treadmill system (C-Mill VR+) under three randomized conditions: 1. Unsupported walking (no arm support), 2. Single-arm support (using the non-paretic side), 3. Dual-arm support (using both arms).

Researchers will record gait speed, step length, cadence, and duration of stance/swing phases for each condition.

Expected Outcome: The findings will provide scientific evidence on how different support strategies modulate walking performance. This information will help physical therapists design more effective, individualized rehabilitation programs to improve mobility and quality of life for stroke survivors.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

Location status: Recruiting

Location contact

Murat Akıncı

CONTACT

[email protected]

+90 552 935 69 78

Murat Akıncı

PRINCIPAL_INVESTIGATOR

Refiye ÖNAL

SUB_INVESTIGATOR

About this study

Study Setting and Population: This study will be conducted at the Ankara Bilkent City Hospital, Physical Therapy and Rehabilitation Hospital. The study population consists of patients receiving treatment for hemiplegia (ICD-10 G.81) due to stroke.

Procedural Overview: Following the initial clinical and demographic assessment (including MoCA, FAC, and Brunnstrom staging), participants will undergo gait analysis under three distinct conditions: Unsupported walking, Single-arm support (using the non-paretic side), Dual-arm support Randomization and Bias Control: To eliminate order and carry-over effects, the sequence of the walking conditions will be randomized and balanced using a predefined table (e.g., ABC, BCA, CAB). While the first condition will be the one the patient feels most comfortable with, the subsequent two conditions will be assigned randomly.

Gait Analysis Protocol:

Acclimatization: Before data collection, a 2-minute familiarization walk will be provided for each condition.

Measurement: Spatiotemporal gait data will be recorded for 2 minutes using the C-Mill VR+ system, which utilizes a force-plate integrated treadmill (100 cm x 240 cm) with a 500 Hz sampling frequency.

Safety and Fatigue Management: To prevent fatigue, a minimum rest period of 2 minutes will be provided between trials. The rest period will be extended if the participant's perceived exertion (Borg RPE) exceeds 10. A physiotherapist will accompany the participant throughout the test to ensure safety and prevent falls.

Standardization: Participants will wear comfortable athletic shoes. If the participant uses an Ankle-Foot Orthosis (AFO) or other orthotics, these will be maintained consistently across all three walking conditions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of hemiplegia with ICD-10 code G.81.
  • Presence of unilateral hemiplegia.
  • No medical contraindications for the use of assistive devices (e.g., cane, tripod).
  • Aged 18 years or older.
  • Ability to walk for at least 2 consecutive minutes.

Exclusion criteria

  • Presence of aphasia.
  • Recurrent stroke.
  • Montreal Cognitive Assessment (MoCA) score below 10 points.

Treatment and study plan

C-Mill VR+ (Force-plate integrated treadmill)

Device

Description: A treadmill system equipped with integrated force plates and augmented reality (VR) capabilities. It records spatiotemporal gait data at a 500 Hz sampling frequency. In this study, the device is used to measure gait parameters under different upper extremity support conditions.

No Support Protocol

Behavioral

The standardized protocol of walking under no support: Natural walking with free arm swing. Each trial lasts 2 minutes with mandatory rest periods to prevent fatigue.

Unilateral Support Protocol

Behavioral

The standardized protocol of walking under unilateral support: Holding the handrail with the non-paretic hand. Each trial lasts 2 minutes with mandatory rest periods to prevent fatigue.

Bilateral Support Protocol

Behavioral

The standardized protocol of walking under bilateral support: Holding the handrails with both hands. Each trial lasts 2 minutes with mandatory rest periods to prevent fatigue.

Primary outcomes

  1. Cadence

    Time frame: At the end of each 2-minute walking condition during the single study session.

    Data will be collected using the C-Mill VR+ force-plate integrated treadmill system at a sampling frequency of 500 Hz. These parameters will be used to compare the biomechanical differences between unsupported, single-arm, and dual-arm supported walking.

  2. Stride length

    Time frame: At the end of each 2-minute walking condition during the single study session.

    Data will be collected using the C-Mill VR+ force-plate integrated treadmill system at a sampling frequency of 500 Hz. These parameters will be used to compare the biomechanical differences between unsupported, single-arm, and dual-arm supported walking.

  3. Double Support Time

    Time frame: At the end of each 2-minute walking condition during the single study session.

    Data will be collected using the C-Mill VR+ force-plate integrated treadmill system at a sampling frequency of 500 Hz. These parameters will be used to compare the biomechanical differences between unsupported, single-arm, and dual-arm supported walking.

Secondary outcomes

  1. Functional Walking Speed (10-Meter Walk Test)

    Time frame: Baseline (at the beginning of the study session).

    The 10-Meter Walk Test (10MWT) will be used to assess the patient's functional walking speed. The time taken to walk the middle 10 meters of a 14-meter path at a comfortable pace will be recorded in seconds and converted to kilometers per hour (km/h).

  2. Functional Ambulation Category (FAC)

    Time frame: Baseline (at the beginning of the study session).

    A 6-point scale (0-5) used to assess the level of physical support required by the patient during walking. 0 indicates the patient cannot walk or requires help from 2 people; 5 indicates the patient can walk independently anywhere.

  3. Hemiplegic Side Step Length

    Time frame: At the end of each 2-minute walking condition during the single study session.

    Data will be collected using the C-Mill VR+ force-plate integrated treadmill system at a sampling frequency of 500 Hz. These parameters will be used to compare the biomechanical differences between unsupported, single-arm, and dual-arm supported walking.

  4. Hemiplegic Stance Time

    Time frame: At the end of each 2-minute walking condition during the single study session.

    Data will be collected using the C-Mill VR+ force-plate integrated treadmill system at a sampling frequency of 500 Hz. These parameters will be used to compare the biomechanical differences between unsupported, single-arm, and dual-arm supported walking.

  5. Non-Hemiplegic Stance Time

    Time frame: At the end of each 2-minute walking condition during the single study session.

    Data will be collected using the C-Mill VR+ force-plate integrated treadmill system at a sampling frequency of 500 Hz. These parameters will be used to compare the biomechanical differences between unsupported, single-arm, and dual-arm supported walking.

  6. Non-Hemiplegic Step Length

    Time frame: At the end of each 2-minute walking condition during the single study session.

    Data will be collected using the C-Mill VR+ force-plate integrated treadmill system at a sampling frequency of 500 Hz. These parameters will be used to compare the biomechanical differences between unsupported, single-arm, and dual-arm supported walking.

Study contacts

Contact information is provided by the study sponsor or research team.

Murat AKINCI

CONTACT

[email protected]

+90 552 935 69 78

Sponsors and collaborators

Lead sponsor

Ankara Yildirim Beyazıt University

Other

Registry information

Official study title

The Effect of Upper Extremity Support Usage on Spatiotemporal Gait Parameters in Individuals With Stroke: A Prospective Cross-over Experimental Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.