Self-Practicing Upper Body Exercises with a Robotic Trainer System

NCT06690658 | Recruiting

• 1 other identifier: 0007-23-LOE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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:

1. 1.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)
2. 2.To document unexpected adverse events during training.
3. 3.To assess the resources and ability to manage and implement the training (i.e., administrative capacity, technology and equipment needs and training).

Conditions

Robot Assisted Therapy; Training

Outcome Measures

Primary Outcomes (1)

• Training attendance

  From enrollment to end of treatment at 3-4 weeks

Secondary Outcomes (4)

• Time on task (in minutes)

  From enrollment to end of treatment at 3-4 weeks.

• The physical activity enjoyment scale

  From enrollment to end of treatment at 3-4 weeks.

• User Experience Questionnaire - Short Version (UEQ-S)

  From enrollment to end of treatment at 3-4 weeks.

• Almere Model scale

  From enrollment to end of treatment at 3-4 weeks.

Study Arms (1)

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.

Device: incorporating robotic system for upper body physical training of people with lower limb orthopedic condition

Interventions

incorporating robotic system for upper body physical training of people with lower limb orthopedic condition DEVICE

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.

Thirty people with lower limb orthopedic injury or lower limb amputation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years ≤ Age
• stable clinical and metabolic state
• ability to sit without back support independently
• ability to understand research instructions.

You may not qualify if:

• A contraindication to perform active upper extremity movements
• Severe pain that limits the ability to exercise.

Sponsors & Collaborators

• Loewenstein Hospital: lead

Study Sites (1)

Loewenstein Hospital

Raanana, Israel, Israel

RECRUITING

Central Study Contacts

Shirley Handelzalts, Dr+

CONTACT

+972-9-7709010; ShirleyH@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 15, 2024
• Study Start: January 21, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 14, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

IL (1)