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

March 23, 2026 updated by: Murat Akıncı, Ankara Yildirim Beyazıt University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06800
        • Recruiting
        • Ankara Bilkent City Hospital
        • Contact:
        • Principal Investigator:
          • Murat Akıncı
        • Sub-Investigator:
          • Refiye ÖNAL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Unsupported Walking
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)
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.
Experimental: Single-Arm Support
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)
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: 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.
Experimental: Dual-Arm Support
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)
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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cadence
Time Frame: At 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.
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.
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
Time Frame: At 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.
At the end of each 2-minute walking condition during the single study session.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Yildirim Beyazıt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 11, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Stroke08

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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