StrokeNCT07036900
Effects of Flexion and Extension Type Arm Slings on Walking Kinematics and Balance in Stroke Patients
An observational study of Stroke, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
In the clinic, stroke patients are seen to use flexor or extensor type arm slings, but no study was found investigating the effects of these different types of arm slings on walking kinematics and balance. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2024to 30 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This prospective, randomized controlled study involved ambulatory stroke patients (experimental group (EG)) and healthy individuals (control group (CG)).
Who may be able to join
- Stroke diagnosis,
- Age 18-80,
- Independent ambulation (Functional Ambulation Category-FAS ≥ 2),
- Modified Ashworth Scale-MAS ≤2 for gastrocnemius and biceps muscles,
- Ability to walk 10 m independently or with assistive device, (6) physician approval for an exercise program.
- Healthy individuals without any additional neurological or orthopaedic diseases that may affect balance and gait,
- Age 18-80
- Physician approval for an exercise program.
Who cannot join
- Severe visual impairments,
- Cerebellar involvement
- Upper extremity Brunnstrom stage ≤ 3,
- Cancer diagnosis
- Presence of a neurological or orthopedic condition other than stroke,
- Inability to understand and follow commands or lack of cooperation
Trial locations and contacts
1 site in 1 country.
About this study
In the clinic, stroke patients are seen to use flexor or extensor type arm slings, but no study was found investigating the effects of these different types of arm slings on walking kinematics and balance. The aim of the presented study was to investigate the effects of different types of arm slings on walking kinematics and balance in stroke patients and to compare them with healthy individuals.
Read the detailed description
Stroke is one of the most common diseases in the world, affecting one in every four people (Campbell \& Khatri, 2020). After stroke, approximately 80% of patients experience walking disorders (Algurén et al., 2010). Stroke survivors demonstrate gait disturbances such as reduced walking speed, step length and cadence (Balaban \& Tok, 2014). Deterioration in walking kinematics negatively affects daily living activities, confidence, self-care, social roles, family life and reducing quality of life in stroke survivors (Park \& Kim, 2019). Additionally, walking disturbances in stoke patients can lead to increased energy expenditure, pain and risk of falling (Balaban \& Tok, 2014; Shin et al., 2020). Besides, balance impairments are frequent clinical symptom in stroke survivors. Compared to healthy individuals, stroke patients have lower balance and walking capacity. Accordingly, the risk of falling increases, physical activity and participation reduces in individuals with stroke (Roelofs et al., 2023). Therefore, it is important that walking kinematics and balance in stroke survivors should have similar characteristics to the healthy individuals.
One of the frequently complications after stroke is shoulder subluxations. Shoulder subluxation increases the distance between the acromion and the humeral head, thus delay improvement of upper extremity motor function and decrease proprioception in stroke survivors (Paci et al., 2005). Electrical stimulation, robot-assisted upper extremity rehabilitation and arm slings are the physiotherapy and rehabilitation applications used to prevent shoulder subluxations in stroke patients (Jung \& Choi, 2019; Paci et al., 2005). Arm slings are often used to help reposition the humeral head in the glenoid fossa by counteracting gravity on the affected side (Jeong et al., 2022). In addition, it has been stated that arm slings have a positive effect on balance, increase walking efficiency, reduce spasticity and are a painless application in stroke survivors (Acar \& Karatas, 2010; Jeong et al., 2022). In the clinic, it has been observed that stroke patients use flexor or extensor type arm slings. However, no study has been found investigating the effects of these different types of arm slings on walking kinematics and balance in stroke patients. The aim of the presented study is to investigate different types of arm slings on walking kinematics and balance in stroke patients and compare with the healthy individuals.
- Conditions
- Stroke
- Being tested
- No Interventions
- Keywords
- Arm Slings, Walking Kinematics, Balance, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionsOther
There is no treatment to be administered within the scope of this study.
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients (experimental group (EG)) | All test assesments were explained to the patient both verbally and visually. All assesments were applied for patients and healthy participants on the same day. Patients using assistive devices were assessed with these devices. Participants were initially assessed for gait analysis without an arm sling. Then, assessments were conducted by applying a flexor arm sling first, followed by an extensor arm sling. The assessments and data collection were conducted by physiotherapists. Receives: Other: No Interventions | |
| Healthy individuals (control group (CG)) | All test assesments were explained to the patient both verbally and visually. All assesments were applied for patients and healthy participants on the same day. Patients using assistive devices were assessed with these devices. Participants were initially assessed for gait analysis without an arm sling. Then, assessments were conducted by applying a flexor arm sling first, followed by an extensor arm sling. The assessments and data collection were conducted by physiotherapists. Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
PABLO ® Lower Extremity inertial sensor
Inertial measurement unit (IMU) systems have been validated for measuring joint angles and temporal characteristics during lower extremity movements (O'Reilly et al., 2018). Gait parameters, such as stance and swing phase durations, step length, walking speed, and cadence, can be determined using two inertial sensors placed in the shoes. Each shoe is equipped with a PABLO Lower Extremity Inertial Sensor. The sensors measure angular velocity and acceleration at a sampling frequency of 110Hz. Each sensor transmits data via Bluetooth. The sensors are attached to the participants' shoes using custom Velcro straps. It has been found that inertial measurement unit systems work reliably not only in healthy individuals but also in patients, providing accurate results under different pathological gait patterns (Laidig et al., 2021). In our study, gait analysis was conducted to establish reference values by evaluating stroke patients and healthy individuals of the same age.
Measured: 8 minutes (approximately)
TYMO ® Balance Plate
The TYMO® Balance Plate (Tyromotion, Austria) is a standardized balance analysis device used to assess posture and balance in an upright stance. The TYMO® force sensors detect weight shifting and measure the center of pressure, body sway, and load balance on the feet. These data provide indicators of balance, stability, and symmetry. The TYMO® system is a versatile and easy-to-use assessment and treatment tool consisting of the TYMO Therapy Board and software. Participants are required to stand on a platform for 30 seconds and undergo four test positions: 1) feet apart, eyes open, firm support surface; 2) feet apart, eyes closed, firm support surface; 3) feet apart, eyes open, soft support surface/foam; 4) feet apart, eyes closed, soft support surface/foam. Each position was tested once, and the displacement of the center of body mass was measured in centimeters (Dudoniene et al., 2023).
Measured: 8-10 minutes (approximately)
Secondary outcomes (1)
Timed Up and Go Test
The Timed Up and Go test is used to assess a person's walking speed, fall risk, and mobility (Wall et al., 2000). In this test, the patient is instructed to stand up from a chair, walk a previously marked 3-meter distance, turn, and then return to sit back down in the chair. The average time in seconds is recorded after three repetitions to find the result. A completion time longer than 13.5 seconds is considered indicative of an increased fall risk, while a time exceeding 20 seconds is associated with decreased mobility (Podsiadlo \& Richardson, 1991).
Measured: 3-5 minutes (approximately)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start30 Dec 2024
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
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 Istanbul University - CerrahpasaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceren Bayrak, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036900
- Sponsor's protocol ID
- ODGQzpAt
- Status last verified
- Oct 2026
- First submitted
- 17 Jun 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is planned that patient data will not be shared with anyone.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Flexion and Extension Type Arm Slings on Walking Kinematics and Balance in Stroke Patients
- ClinicalTrials.gov ID
- NCT07036900
- Acronym / sponsor ID
- ODGQzpAt
- Conditions
- Stroke
- Keywords
- Arm Slings, Walking Kinematics, Balance, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 25 Jun 2025 (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.
In the clinic, stroke patients are seen to use flexor or extensor type arm slings, but no study was found investigating the effects of these different types of arm slings on walking kinematics and balance. The aim of the presented study was to investigate the effects of different types of arm slings on walking kinematics and balance in stroke patients and to compare them with healthy individuals.
Detailed description
Stroke is one of the most common diseases in the world, affecting one in every four people (Campbell \& Khatri, 2020). After stroke, approximately 80% of patients experience walking disorders (Algurén et al., 2010). Stroke survivors demonstrate gait disturbances such as reduced walking speed, step length and cadence (Balaban \& Tok, 2014). Deterioration in walking kinematics negatively affects daily living activities, confidence, self-care, social roles, family life and reducing quality of life in stroke survivors (Park \& Kim, 2019). Additionally, walking disturbances in stoke patients can lead to increased energy expenditure, pain and risk of falling (Balaban \& Tok, 2014; Shin et al., 2020). Besides, balance impairments are frequent clinical symptom in stroke survivors. Compared to healthy individuals, stroke patients have lower balance and walking capacity. Accordingly, the risk of falling increases, physical activity and participation reduces in individuals with stroke (Roelofs et al., 2023). Therefore, it is important that walking kinematics and balance in stroke survivors should have similar characteristics to the healthy individuals.
One of the frequently complications after stroke is shoulder subluxations. Shoulder subluxation increases the distance between the acromion and the humeral head, thus delay improvement of upper extremity motor function and decrease proprioception in stroke survivors (Paci et al., 2005). Electrical stimulation, robot-assisted upper extremity rehabilitation and arm slings are the physiotherapy and rehabilitation applications used to prevent shoulder subluxations in stroke patients (Jung \& Choi, 2019; Paci et al., 2005). Arm slings are often used to help reposition the humeral head in the glenoid fossa by counteracting gravity on the affected side (Jeong et al., 2022). In addition, it has been stated that arm slings have a positive effect on balance, increase walking efficiency, reduce spasticity and are a painless application in stroke survivors (Acar \& Karatas, 2010; Jeong et al., 2022). In the clinic, it has been observed that stroke patients use flexor or extensor type arm slings. However, no study has been found investigating the effects of these different types of arm slings on walking kinematics and balance in stroke patients. The aim of the presented study is to investigate different types of arm slings on walking kinematics and balance in stroke patients and compare with the healthy individuals.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke patients (experimental group (EG)) | – | Other: No InterventionsAll test assesments were explained to the patient both verbally and visually. All assesments were applied for patients and healthy participants on the same day. Patients using assistive devices were assessed with these devices. Participants were initially assessed for gait analysis without an arm sling. Then, assessments were conducted by applying a flexor arm sling first, followed by an extensor arm sling. The assessments and data collection were conducted by physiotherapists. |
| Healthy individuals (control group (CG)) | – | Other: No InterventionsAll test assesments were explained to the patient both verbally and visually. All assesments were applied for patients and healthy participants on the same day. Patients using assistive devices were assessed with these devices. Participants were initially assessed for gait analysis without an arm sling. Then, assessments were conducted by applying a flexor arm sling first, followed by an extensor arm sling. The assessments and data collection were conducted by physiotherapists. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective, randomized controlled study involved ambulatory stroke patients (experimental group (EG)) and healthy individuals (control group (CG)).
Key inclusion criteria (8 listed)
- Stroke diagnosis,
- Age 18-80,
- Independent ambulation (Functional Ambulation Category-FAS ≥ 2),
- Modified Ashworth Scale-MAS ≤2 for gastrocnemius and biceps muscles,
- Ability to walk 10 m independently or with assistive device, (6) physician approval for an exercise program.
Key exclusion criteria (6 listed)
- Severe visual impairments,
- Cerebellar involvement
- Upper extremity Brunnstrom stage ≤ 3,
- Cancer diagnosis
- Presence of a neurological or orthopedic condition other than stroke,
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 |
|---|---|---|
| No InterventionsThere is no treatment to be administered within the scope of this study. | Other | Healthy individuals (control group (CG)), Stroke patients (experimental group (EG)) |
Primary outcome
PABLO ® Lower Extremity inertial sensor
Time frame: 8 minutes (approximately)
Inertial measurement unit (IMU) systems have been validated for measuring joint angles and temporal characteristics during lower extremity movements (O'Reilly et al., 2018). Gait parameters, such as stance and swing phase durations, step length, walking speed, and cadence, can be determined using two inertial sensors placed in the shoes. Each shoe is equipped with a PABLO Lower Extremity Inertial Sensor. The sensors measure angular velocity and acceleration at a sampling frequency of 110Hz. Each sensor transmits data via Bluetooth. The sensors are attached to the participants' shoes using custom Velcro straps. It has been found that inertial measurement unit systems work reliably not only in healthy individuals but also in patients, providing accurate results under different pathological gait patterns (Laidig et al., 2021). In our study, gait analysis was conducted to establish reference values by evaluating stroke patients and healthy individuals of the same age.
TYMO ® Balance Plate
Time frame: 8-10 minutes (approximately)
The TYMO® Balance Plate (Tyromotion, Austria) is a standardized balance analysis device used to assess posture and balance in an upright stance. The TYMO® force sensors detect weight shifting and measure the center of pressure, body sway, and load balance on the feet. These data provide indicators of balance, stability, and symmetry. The TYMO® system is a versatile and easy-to-use assessment and treatment tool consisting of the TYMO Therapy Board and software. Participants are required to stand on a platform for 30 seconds and undergo four test positions: 1) feet apart, eyes open, firm support surface; 2) feet apart, eyes closed, firm support surface; 3) feet apart, eyes open, soft support surface/foam; 4) feet apart, eyes closed, soft support surface/foam. Each position was tested once, and the displacement of the center of body mass was measured in centimeters (Dudoniene et al., 2023).
1 secondary outcome
Timed Up and Go Test
Time frame: 3-5 minutes (approximately)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- articleLink provided by the sponsor.
- articleLink provided by the sponsor.
- articleLink provided by the sponsor.
- articleLink provided by the sponsor.
- articleLink provided by the sponsor.
- articleLink provided by the sponsor.
- Individual participant dataSharing planned: No. It is planned that patient data will not be shared with anyone.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Istanbul University - Cerrahpasa 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 8 inclusion and 6 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: finished, as of the sponsor's last update on 3 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PABLO ® Lower Extremity inertial sensor (time frame: 8 minutes (approximately)). The study lists 2 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 3 Nov 2026.