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

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnkara Yildirim Beyazıt University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Presence of aphasia.

Recurrent stroke.

Montreal Cognitive Assessment (MoCA) score below 10 points.

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

34 Participants
are divided into 3 treatment groups
Group A: Unsupported WalkingExperimental treatment 2 interventions
Group B: Single-Arm SupportExperimental treatment 2 interventions
Group C: Dual-Arm SupportExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

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

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.

Time frame
At the end of each 2-minute walking condition during the single study session.
3

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.

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

Secondary outcomes

1

Functional Walking Speed (10-Meter Walk Test)

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).

Time frame
Baseline (at the beginning of the study session).
2

Functional Ambulation Category (FAC)

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.

Time frame
Baseline (at the beginning of the study session).
3

Hemiplegic Side Step 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.

Time frame
At the end of each 2-minute walking condition during the single study session.
4

Hemiplegic Stance 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.

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

Other outcomes

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