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

Official title

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

Overview

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

• Device C-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.
• Behavioral No 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.
• Behavioral Unilateral 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.
• Behavioral Bilateral 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.

Primary outcome measures

• Cadence [Time frame: At the end of each 2-minute walking condition during the single study session.]
• Stride length [Time frame: At the end of each 2-minute walking condition during the single study session.]
• Double Support Time [Time frame: At the end of each 2-minute walking condition during the single study session.]

Secondary outcome measures (6)

• Functional Walking Speed (10-Meter Walk Test) [Time frame: Baseline (at the beginning of the study session).]
• Functional Ambulation Category (FAC) [Time frame: Baseline (at the beginning of the study session).]
• Hemiplegic Side Step Length [Time frame: At the end of each 2-minute walking condition during the single study session.]
• Hemiplegic Stance Time [Time frame: At the end of each 2-minute walking condition during the single study session.]
• Non-Hemiplegic Stance Time [Time frame: At the end of each 2-minute walking condition during the single study session.]
• Non-Hemiplegic Step Length [Time frame: At the end of each 2-minute walking condition during the single study session.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Basic science

Study locations

Turkey (Türkiye) · 1 center

• Ankara Bilkent City Hospital — Ankara

Identifiers

NCT: NCT07496853 · Stroke08

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗