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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07496853
Enrollment
34
Registered
2026-03-27
Start date
2026-04-01
Completion date
2026-12-31
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Stroke, Gait Analysis, arm swing, upper extremity, spatiotemporal

Brief summary

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.

Detailed description

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.

Interventions

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

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.

BEHAVIORALNo Support Protocol

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.

BEHAVIORALUnilateral Support Protocol

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.

BEHAVIORALBilateral Support Protocol

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.

Sponsors

Ankara Yildirim Beyazıt University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

This is a prospective crossover study where each participant serves as their own control. All participants perform the walking tasks under three different conditions: unsupported, single-arm support, and dual-arm support. To prevent order and carry-over effects, the sequence of conditions is randomized and counterbalanced for each participant.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
CadenceAt 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.
Stride lengthAt 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.
Double Support TimeAt 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

MeasureTime frameDescription
Functional Walking Speed (10-Meter Walk Test)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).
Functional Ambulation Category (FAC)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.
Hemiplegic Side Step LengthAt 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.
Hemiplegic Stance TimeAt 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.
Non-Hemiplegic Stance TimeAt 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.
Non-Hemiplegic Step LengthAt 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.

Countries

Turkey (Türkiye)

Contacts

CONTACTMurat AKINCI
muratakinci.fzt@gmail.com+90 552 935 69 78

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026