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Exploring the acceptability of upper limb training using an exoskeleton-based robotic device combined with functional training for people with chronic stroke: an embedded mixed-method study

Exploring the acceptability of upper limb training using an exoskeleton-based robotic device combined with functional training for people with chronic stroke: an embedded mixed-method study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625001218482
Enrollment
12
Registered
2025-11-04
Start date
2025-11-17
Completion date
2027-01-04
Last updated
2025-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study aims to explore the acceptability of combining robotic training using KinArm Exoskeleton device and functional training. By exploring the acceptability of this training protocol, it would provide the necessary steps to improve the implementation of a robotic training for people with arm and hand weakness after stroke. Also, we would also aim to investigate if combining robotic and functional training for 10 sessions can improve arm/hand strength and function of people who had stroke.

Interventions

Participants will undergo one-on-one upper limb training over a 4-week period (thrice per week and 1 session at final week) administered by a physiotherapist, comprising 10 sessions in total. Each session will last 1.5 hours and include: - 30 minutes for setup, warm-up, and cool-down - 60 minutes of focused training using a robotic device and functional tasks Training is tailored to each participant’s needs. At the start of each session, the level of assistance or task difficulty will be brief

Participants will undergo one-on-one upper limb training over a 4-week period (thrice per week and 1 session at final week) administered by a physiotherapist, comprising 10 sessions in total. Each session will last 1.5 hours and include: - 30 minutes for setup, warm-up, and cool-down - 60 minutes of focused training using a robotic device and functional tasks Training is tailored to each participant’s needs. At the start of each session, the level of assistance or task difficulty will be briefly assessed by the physiotherapist. At the end, a session form will be completed by the physiotherapist to document the adherence to the intervention, participant’s response including rate of perceived exertion using Borg, number of repetitions performed, and any adverse events. Robotic Training Component The robotic device used is the KinArm Exoskeleton Device (BKIN Technologies). During robotic training: - Participant's arms will be supported by the exoskeleton and will be asked to performing shoulder horizontal abduction/adduction and elbow flexion and extension depending on the tasks seen on the screen. Total sessions are 30 minutes. - As the participant moves, the machine records the quality of the movement and the number of error if applicable. - Each task includes a scoring system, adjustable assistance/resistance, and difficulty levels - Task difficulty will be progressively adjusted across sessions based on performance Functional Training Component Functional training will target all major joints of the upper limb. Tasks will include: - Overhead reaching activities - Elbow flexion and extension - Hand and finger dexterity exercises - Combined movements that simulate daily activities Each task will be performed for 3 sets of 10 repetitions. If time permits, the same set of tasks will be repeated. Training Location All sessions will be conducted at the NeuroRehabilitation and Robotics Laboratory, Edith Cowan University

Sponsors

Edith Cowan University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Diagnosed with haemorrhagic or ischemic stroke at least 6 months prior to enrolment 2. Moderate to severe upper limb impairment 3. No cognitive problems (mini-mental of > 24) 4. Able to attend 4-week training sessions, and assessment sessions including one follow-up session 5. Participant needs to have visual and/or auditory acuity to permit adequate perception of instructions or task stimuli.

Exclusion criteria

1. Severe spasticity (Modified Ashworth Scale score less than or equal to 3) 2. Uncontrolled co-morbidities like hypertension or heart conditions with contra-indication for high-dosage training 3. Other neurological conditions like SCI, PD and MS 4. Weight of more than 150 kg (maximum weight limitation of the device)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026