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

NCT07496853 | Recruiting

• 1 other identifier: Stroke08
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Cadence

  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.

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

• Stride length

  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.

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

• Double Support Time

  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.

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

Secondary Outcomes (6)

• Functional Walking Speed (10-Meter Walk Test)

  Baseline (at the beginning of the study session).

• Functional Ambulation Category (FAC)

  Baseline (at the beginning of the study session).

• Hemiplegic Side Step Length

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

• Hemiplegic Stance Time

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

• Non-Hemiplegic Stance Time

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

Study Arms (3)

Unsupported Walking

EXPERIMENTAL

Participants will walk on the C-Mill VR+ treadmill at their comfortable walking speed without using any upper extremity support or handrails. This condition serves as the baseline for gait spatiotemporal parameters.

Device: C-Mill VR+ (Force-plate integrated treadmill); Behavioral: No Support Protocol

Single-Arm Support

EXPERIMENTAL

Participants will walk on the C-Mill VR+ treadmill while using only their non-paretic (stronger) upper extremity for support on the handrail. This condition simulates the use of a single-sided walking aid (like a cane or tripod).

Device: C-Mill VR+ (Force-plate integrated treadmill); Behavioral: Unilateral Support Protocol

Dual-Arm Support

EXPERIMENTAL

Participants will walk on the C-Mill VR+ treadmill while using both upper extremities for support on the handrails. This condition represents maximal upper limb support during gait, commonly seen in early rehabilitation or parallel bar training.

Device: C-Mill VR+ (Force-plate integrated treadmill); Behavioral: Bilateral Support Protocol

Interventions

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.

Dual-Arm Support; Single-Arm Support; Unsupported Walking

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.

Unsupported Walking

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.

Single-Arm Support

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.

Dual-Arm Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, 06800, Turkey (Türkiye)

RECRUITING

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

Murat AKINCI

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

TU (1)