Robot Assisted TherapyNCT06690658
Self-Practicing Upper Body Exercises With a Robotic Trainer System
A study testing incorporating robotic system for upper body physical training of people with lower limb orthopedic condition in people with Robot Assisted Therapy and Training, run by Loewenstein Hospital at 1 site in Israel.
Trial summary
Studies suggest that older adults undergoing inpatient rehabilitation have relatively low levels of physical activity. Moreover, people with lower limb orthopedic conditions undergoing inpatient rehabilitation may be particularly vulnerable to the consequences of low physical activity because of the mobility… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Robot Assisted Therapy, Training
- What is being tested?
- incorporating robotic system for upper body physical training of people with lower limb orthopedic condition
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 21 Jan 2025to Jan 2027
- 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
- 18 years ≤ Age
- stable clinical and metabolic state
- ability to sit without back support independently
- ability to understand research instructions.
Who cannot join
- A contraindication to perform active upper extremity movements
- Severe pain that limits the ability to exercise.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Loewenstein Hospital
Raanana, Israel
Shirley Handelzalts, Dr, +972-9-7709010, shirleyh@clalit.org.il
About this study
Official title: Self-Practicing Upper Body Exercises With a Robotic Trainer System in the Physical Therapy Department: A Feasibility Study
Studies suggest that older adults undergoing inpatient rehabilitation have relatively low levels of physical activity. Moreover, people with lower limb orthopedic conditions undergoing inpatient rehabilitation may be particularly vulnerable to the consequences of low physical activity because of the mobility limitations.
The study focuses on examining the feasibility of incorporating robotic system for upper body physical training of people with lower limb orthopedic condition undergoing inpatient rehabilitation. Using robotic coaches can be a complementary method to promote the participation and motivation of people with lower limb orthopedic conditions undergoing inpatient rehabilitation.
Read more
Aims:
The overall aim of the study is to assess the user experience and feasibility of incorporating robotic system for upper body physical training of people with lower limb orthopedic injury/condition undergoing inpatient rehabilitation. Our specific aims are:
- To assess the acceptability and suitability of the training (i.e., training attendance and engagement; adherence to training protocol; time on task; satisfaction and enjoyment of the training)
- To document unexpected adverse events during training.
- To assess the resources and ability to manage and implement the training (i.e., administrative capacity, technology and equipment needs and training).
Read the detailed description
The training will be conducted in a designated area in the physical therapy hall. After completing the consent form, participants will be asked to fill pre-experiments questionnaires including demographic information as well as details about their profession, education, and other personal attributes, Negative Attitude towards Robots (NARS) questionnaire, and Technology Adoption Propensity (TAP) Questionnaire. The physical therapist, together with the patient, will choose specific strengthening and flexibility exercises from multiple options according to participant's ability and training goals. The physical therapist will explain about the system and how it works prior to the beginning of the session. In addition, to ensure that each patient can access their customized training, each patient will be assigned a unique number before the first session, which they will use to log into the system The patient together with the physical therapist will schedule the time for the patient to self-practice with the system, 3 times per week for 3 weeks. A training session begins with the robot introducing itself, and the participant sits in front of the robot. The robot will demonstrate upper body exercises and will provide verbal instructions and feedback (e.g, number of successful repetitions, motivational). At the beginning of the session, the participant will be asked to follow the robot's demonstration and simultaneously perform the exercise. At the end of each exercise, the robot will provide feedback. If the participant successfully performed ten repetitions of the required exercise in the demonstration time allocated, positive feedback will be provided. Resistance (strengthening) exercises for the upper body include lifting weights, working with resistance bands in different directions involving the upper extremity and trunk. Flexibility exercises include upper extremity and trunk stretching. Rest breaks will be provided as needed during the session. Participants will be able to stop the training at any time. During the training, the system will collect data regarding the success of the exercises in excel files without any identifiable data. When completing the training program, the users will be asked to fill in questionnaires. During all training sessions, a physical therapist will be present in the room to provide guidance and supervision, ensuring that the exercises are performed correctly and do not induce pain or fatigue. The therapist will also review the kinematic data collected in each session to monitor progression and adjust the program (such as increasing or decreasing exercise difficulty). After each session, the participant will be asked to rate his perceived rate of exertion using the Borg scale (0 to 10 scale) on the robot's screen and will be offered to start the training session from the beginning.
- Conditions
- Robot Assisted Therapy, Training
- Being tested
- incorporating robotic system for upper body physical training of people with lower limb orthopedic condition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
incorporating robotic system for upper body physical training of people with lower limb orthopedic conditionDevice
A training session begins with the robot introducing itself, and the participant sits in front of the robot. The robot will demonstrate upper body exercises and will provide verbal instructions and feedback (e.g, number of successful repetitions, motivational). At the beginning of the session, the participant will be asked to follow the robot's demonstration and simultaneously perform the exercise. At the end of each exercise, the robot will provide feedback. If the participant successfully performed ten repetitions of the required exercise in the demonstration time allocated, positive feedback will be provided. Resistance (strengthening) exercises for the upper body include lifting weights, working with resistance bands in different directions involving the upper extremity and trunk. Flexibility exercises include upper extremity and trunk stretching.
| Study group | Role | What they receive |
|---|---|---|
| Thirty people with lower limb orthopedic injury or lower limb amputation | Other | Participants will be asked to fill pre-experiments questionnaires. Each patient will be assigned a unique number before the first session, which they will use to log into the system.
The patient together with the physical therapist will schedule the time for the patient to self-practice with the system, 3 times per week for 3 weeks, 30 min each session. A training session begins with the robot introducing itself, and the participant sits in front of the robot. The robot will demonstrate upper body exercises and will provide verbal instructions and feedback. The participant will be asked to follow the robot's demonstration and simultaneously perform the exercise. When completing the training program, the users will be asked to fill in questionnaires. After each session, the participant will be asked to rate his perceived rate of exertion using the Borg scale (0 to 10 scale) on the robot's screen and will be offered to start the training session from the beginning. Receives: Device: incorporating robotic system for upper body physical training of people with lower limb orthopedic condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Training attendance
Measured: From enrollment to end of treatment at 3-4 weeks
Secondary outcomes (4)
Time on task (in minutes)
Measured: From enrollment to end of treatment at 3-4 weeks.
The physical activity enjoyment scale
Measured: From enrollment to end of treatment at 3-4 weeks.
User Experience Questionnaire - Short Version (UEQ-S)
Measured: From enrollment to end of treatment at 3-4 weeks.
Almere Model scale
Measured: From enrollment to end of treatment at 3-4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start21 Jan 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robot Assisted TherapyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loewenstein Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, shirley handelzalts, Loewenstein Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690658
- Sponsor's protocol ID
- 0007-23-LOE
- Status last verified
- May 2026
- First submitted
- 13 Nov 2024
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Practicing Upper Body Exercises With a Robotic Trainer System in the Physical Therapy Department: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06690658
- Acronym / sponsor ID
- 0007-23-LOE
- Conditions
- Robot Assisted Therapy, Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Loewenstein HospitalUniversity, hospital or other
- Study start
- 21 Jan 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 15 Nov 2024 (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.
Studies suggest that older adults undergoing inpatient rehabilitation have relatively low levels of physical activity. Moreover, people with lower limb orthopedic conditions undergoing inpatient rehabilitation may be particularly vulnerable to the consequences of low physical activity because of the mobility limitations.
The study focuses on examining the feasibility of incorporating robotic system for upper body physical training of people with lower limb orthopedic condition undergoing inpatient rehabilitation. Using robotic coaches can be a complementary method to promote the participation and motivation of people with lower limb orthopedic conditions undergoing inpatient rehabilitation.
Aims:
The overall aim of the study is to assess the user experience and feasibility of incorporating robotic system for upper body physical training of people with lower limb orthopedic injury/condition undergoing inpatient rehabilitation. Our specific aims are:
- To assess the acceptability and suitability of the training (i.e., training attendance and engagement; adherence to training protocol; time on task; satisfaction and enjoyment of the training)
- To document unexpected adverse events during training.
- To assess the resources and ability to manage and implement the training (i.e., administrative capacity, technology and equipment needs and training).
Detailed description
The training will be conducted in a designated area in the physical therapy hall. After completing the consent form, participants will be asked to fill pre-experiments questionnaires including demographic information as well as details about their profession, education, and other personal attributes, Negative Attitude towards Robots (NARS) questionnaire, and Technology Adoption Propensity (TAP) Questionnaire. The physical therapist, together with the patient, will choose specific strengthening and flexibility exercises from multiple options according to participant's ability and training goals. The physical therapist will explain about the system and how it works prior to the beginning of the session. In addition, to ensure that each patient can access their customized training, each patient will be assigned a unique number before the first session, which they will use to log into the system The patient together with the physical therapist will schedule the time for the patient to self-practice with the system, 3 times per week for 3 weeks. A training session begins with the robot introducing itself, and the participant sits in front of the robot. The robot will demonstrate upper body exercises and will provide verbal instructions and feedback (e.g, number of successful repetitions, motivational). At the beginning of the session, the participant will be asked to follow the robot's demonstration and simultaneously perform the exercise. At the end of each exercise, the robot will provide feedback. If the participant successfully performed ten repetitions of the required exercise in the demonstration time allocated, positive feedback will be provided. Resistance (strengthening) exercises for the upper body include lifting weights, working with resistance bands in different directions involving the upper extremity and trunk. Flexibility exercises include upper extremity and trunk stretching. Rest breaks will be provided as needed during the session. Participants will be able to stop the training at any time. During the training, the system will collect data regarding the success of the exercises in excel files without any identifiable data. When completing the training program, the users will be asked to fill in questionnaires. During all training sessions, a physical therapist will be present in the room to provide guidance and supervision, ensuring that the exercises are performed correctly and do not induce pain or fatigue. The therapist will also review the kinematic data collected in each session to monitor progression and adjust the program (such as increasing or decreasing exercise difficulty). After each session, the participant will be asked to rate his perceived rate of exertion using the Borg scale (0 to 10 scale) on the robot's screen and will be offered to start the training session from the beginning.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Thirty people with lower limb orthopedic injury or lower limb amputation | Other | Device: incorporating robotic system for upper body physical training of people with lower limb orthopedic conditionParticipants will be asked to fill pre-experiments questionnaires. Each patient will be assigned a unique number before the first session, which they will use to log into the system. The patient together with the physical therapist will schedule the time for the patient to self-practice with the system, 3 times per week for 3 weeks, 30 min each session. A training session begins with the robot introducing itself, and the participant sits in front of the robot. The robot will demonstrate upper body exercises and will provide verbal instructions and feedback. The participant will be asked to follow the robot's demonstration and simultaneously perform the exercise. When completing the training program, the users will be asked to fill in questionnaires. After each session, the participant will be asked to rate his perceived rate of exertion using the Borg scale (0 to 10 scale) on the robot's screen and will be offered to start the training session from the beginning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years ≤ Age
- stable clinical and metabolic state
- ability to sit without back support independently
- ability to understand research instructions.
Key exclusion criteria (2 listed)
- A contraindication to perform active upper extremity movements
- Severe pain that limits the ability to exercise.
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 |
|---|---|---|
| incorporating robotic system for upper body physical training of people with lower limb orthopedic conditionA training session begins with the robot introducing itself, and the participant sits in front of the robot. The robot will demonstrate upper body exercises and will provide verbal instructions and feedback (e.g, number of successful repetitions, motivational). At the beginning of the session, the participant will be asked to follow the robot's demonstration and simultaneously perform the exercise. At the end of each exercise, the robot will provide feedback. If the participant successfully performed ten repetitions of the required exercise in the demonstration time allocated, positive feedback will be provided. Resistance (strengthening) exercises for the upper body include lifting weights, working with resistance bands in different directions involving the upper extremity and trunk. Flexibility exercises include upper extremity and trunk stretching. | Device | Thirty people with lower limb orthopedic injury or lower limb amputation |
Primary outcome
Training attendance
Time frame: From enrollment to end of treatment at 3-4 weeks
4 secondary outcomes
Time on task (in minutes)
Time frame: From enrollment to end of treatment at 3-4 weeks.
The physical activity enjoyment scale
Time frame: From enrollment to end of treatment at 3-4 weeks.
User Experience Questionnaire - Short Version (UEQ-S)
Time frame: From enrollment to end of treatment at 3-4 weeks.
Almere Model scale
Time frame: From enrollment to end of treatment at 3-4 weeks.
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 May 2026.
- Individual participant dataSharing planned: Yes
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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 incorporating robotic system for upper body physical training of people with lower limb orthopedic condition in people with Robot Assisted Therapy and Training, run by Loewenstein Hospital at 1 site in Israel.
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 4 inclusion and 2 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 May 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 Israel. 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 Shirley Handelzalts, Dr+ (+972-9-7709010, ShirleyH@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Training attendance (time frame: From enrollment to end of treatment at 3-4 weeks). 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 May 2026.