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

Ankara Yildirim Beyazıt University

Status: Enrolling

Conditions: Stroke

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07496853

Stroke08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 3 patient groups

Unsupported Walking

Experimental group

Description:

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.

Treatment:

Behavioral: No Support Protocol

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

Single-Arm Support

Experimental group

Description:

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).

Treatment:

Behavioral: Unilateral Support Protocol

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

Dual-Arm Support

Experimental group

Description:

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.

Treatment:

Behavioral: Bilateral Support Protocol

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