StrokeNCT07496853
Effect of Upper Extremity Support on Spatiotemporal Parameters of Gait in Individuals With Stroke
A study testing C-Mill VR+ (Force-plate integrated treadmill), No Support Protocol and Unilateral Support Protocol in people with Stroke, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- C-Mill VR+ (Force-plate integrated treadmill), No Support Protocol and Unilateral Support Protocol
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Presence of aphasia.
- Recurrent stroke.
- Montreal Cognitive Assessment (MoCA) score below 10 points.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara, 06800
Murat Akıncı, +90 552 935 69 78, muratakinci.fzt@gmail.com
Murat Akıncı
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- C-Mill VR+ (Force-plate integrated treadmill), No Support Protocol, Unilateral Support Protocol, Bilateral Support Protocol
- Keywords
- Stroke, Gait Analysis, arm swing, upper extremity, spatiotemporal
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 ProtocolBehavioural
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 ProtocolBehavioural
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 ProtocolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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. Receives: Device: C-Mill VR+ (Force-plate integrated treadmill); Behavioral: Bilateral Support Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At the end of each 2-minute walking condition during the single study session.
Secondary outcomes (6)
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).
Measured: Baseline (at the beginning of the study session).
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.
Measured: Baseline (at the beginning of the study session).
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.
Measured: At the end of each 2-minute walking condition during the single study session.
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.
Measured: At the end of each 2-minute walking condition during the single study session.
Non-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.
Measured: At the end of each 2-minute walking condition during the single study session.
Non-Hemiplegic 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.
Measured: At the end of each 2-minute walking condition during the single study session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Akıncı, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496853
- Sponsor's protocol ID
- Stroke08
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Upper Extremity Support Usage on Spatiotemporal Gait Parameters in Individuals With Stroke: A Prospective Cross-over Experimental Study
- ClinicalTrials.gov ID
- NCT07496853
- Acronym / sponsor ID
- Stroke08
- Conditions
- Stroke
- Keywords
- Stroke, Gait Analysis, arm swing, upper extremity, spatiotemporal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Unsupported Walking | Experimental | Device: C-Mill VR+ (Force-plate integrated treadmill), Behavioral: No Support ProtocolParticipants 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. |
| Single-Arm Support | Experimental | Device: C-Mill VR+ (Force-plate integrated treadmill), Behavioral: Unilateral Support ProtocolParticipants 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). |
| Dual-Arm Support | Experimental | Device: C-Mill VR+ (Force-plate integrated treadmill), Behavioral: Bilateral Support ProtocolParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Presence of aphasia.
- Recurrent stroke.
- Montreal Cognitive Assessment (MoCA) score below 10 points.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Dual-Arm Support, Single-Arm Support, Unsupported Walking |
| No Support ProtocolThe 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. | Behavioural | Unsupported Walking |
| Unilateral Support ProtocolThe 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. | Behavioural | Single-Arm Support |
| Bilateral Support ProtocolThe 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. | Behavioural | Dual-Arm Support |
Primary outcome
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.
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.
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.
6 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-Mill VR+ (Force-plate integrated treadmill), No Support Protocol and Unilateral Support Protocol in people with Stroke, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Murat AKINCI (+90 552 935 69 78, muratakinci.fzt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cadence (time frame: At the end of each 2-minute walking condition during the single study session.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.