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The Effectiveness Of Single Joint Hybrid Assistive Limb (HAL-SJ) Robotic Exoskeleton Therapy In Improving Functional Outcomes Among Workers With Wrist Fractures: A Randomized Controlled Trial

The Effectiveness Of Single Joint Hybrid Assistive Limb (HAL-SJ) Robotic Exoskeleton Therapy In Improving Functional Outcomes Among Workers With Wrist Fractures: A Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000413729
Enrollment
38
Registered
2022-03-10
Start date
2022-12-15
Completion date
2024-12-05
Last updated
2025-09-08

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

Conditions

None listed

Brief summary

Robotic interventions are capable to provide highly repetitive, intensive, and task-specific training required for functional restoration based on current concepts of motor learning, practiced-induce neuroplasticity and muscle plasticity. This study aims to determine the effectiveness of robotic interventions in improving the functions as well as the recovery period following distal radius fracture. The primary objective of this research is to determine the effectiveness of Single Joint Hybrid Assistive Limb (HAL-SJ) robotic therapy in improving functional level, physical performance, and work readiness among workers with wrist fractures after 4 weeks of intervention. It is hypothesized that a 4-week combined conventional therapy and Single Joint Hybrid Assistive Limb (HAL-SJ) robotic therapy provides greater functional level and physical performance improvement among workers with wrist fractures as compared to those receiving conventional therapy alone during the same intervention period.

Interventions

The HAL is a hybrid control system that consists of a ‘Cybernic Voluntary Control (Bio-Cybernic Control)’ and ‘Cybernic Autonomous Control (Cybernic Robot Control)’. The cybernic control system can provide suitable physical support to wearers with various conditions including both healthy persons and physically challenged persons by using the two types of algorithms as complementary controls. The Cybernic Voluntary Control provides physical supports/actions according to the operator’s voluntary

The HAL is a hybrid control system that consists of a ‘Cybernic Voluntary Control (Bio-Cybernic Control)’ and ‘Cybernic Autonomous Control (Cybernic Robot Control)’. The cybernic control system can provide suitable physical support to wearers with various conditions including both healthy persons and physically challenged persons by using the two types of algorithms as complementary controls. The Cybernic Voluntary Control provides physical supports/actions according to the operator’s voluntary intention caused by the bioelectrical signals including muscle activity. The power units of HAL generate power assist torque by amplifying the wearer’s own joint torque estimated from his/her bioelectrical signals, and the support motions are consequently controlled. Bioelectrical signals, including myoelectricity, are useful and reliable information to estimate a human’s motion intentions because the signals are measured just before corresponding visible muscle activities. Thus, the wearer receives physical support directly by an unconscious interface using the bioelectrical signals. In contrary, the Cybernic Autonomous Control autonomously provides a desired functional motion generated according to the wearer’s body constitution, conditions, and purposes of motion support During the intervention session, the participant will perform repetitions of different wrist movements such as extension, flexion, supination and pronation whilst assisted by a robot arm which receives feedback from the bioelectrical signals generated by the muscle movement. The researcher is a certified HAL-SJ operator accredited by Cyberdyne Inc. and is competent to conduct the robotic intervention for the intervention group. Participants will be selected based on the inclusion and exclusion criteria. The selected participants will be informed about the study and only be included in the study after giving their informed consent. The intervention group will receive a 60-minutes HAL-SJ robotic therapy session conducted by the researcher daily on a 5-day/week routine basis within two hours after the conventional therapy sessions. Week 1 Intervention Protocol HAL-SJ – Gentle Mode i) Extension: 50 repetitions; 3 sets ii) Flexion: 50 repetitions; 3 set iii) Supination: 50 repetitions; 3 sets iv) Pronation: 50 repetitions; 3 sets Parameters: Assist Gain: 75-100 Assist Level: x1 Flexion/Extension Signal Balance: 100%/100% Active/Relax Phase: 10 seconds/10 seconds Week 2 Intervention Protocol HAL-SJ – Gentle Mode i) Extension: 50 repetitions; 3 sets ii) Flexion: 50 repetitions; 3 sets iii) Supination: 50 repetitions; 3 sets iv) Pronation: 50 repetitions; 3 sets Parameters: Assist Gain: 50-75 Assist Level: x1 Flexion/Extension Signal Balance: 100% : 100% Active/Relax Phase: 10 seconds/10 seconds Week 3 Intervention Protocol HAL-SJ – Gentle Mode i) Extension: 50 repetitions; 3 sets ii) Flexion: 50 repetitions; 3 sets iii) Supination: 50 repetitions; 3 sets iv) Pronation: 50 repetitions; 3 sets Parameters: Assist Gain: 25-50 Assist Level: x1 Flexion/Extension Signal Balance: i) 50% : 100% ii) 100% : 50% Active/Relax Phase: 10 seconds/10 seconds Week 4 Intervention Protocol HAL-SJ – Gentle Mode i) Extension: 50 repetitions; 3 sets ii) Flexion: 50 repetitions; 3 sets iii) Supination: 50 repetitions; 3 sets iv) Pronation: 50 repetitions; 3 sets Parameters: Assist Gain: 0-25 Assist Level: x1 Flexion/Ext Signal Balance: i) 25% : 100% ii) 100% : 25% Active/Relax Phase: 10 seconds/10 seconds

Sponsors

Chai Siaw Chui
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

a. SOCSO insured Malaysian workers who are on medical leave; have not returned to work; and receiving rehabilitation program at SOCSO Tun Razak Rehabilitation Centre, Melaka b. Wrist fracture involving individual or combined distal radius, distal ulna, distal radioulnar, radiocarpal joint c. Extraarticular fracture, partial articular fracture, and/or complete articular fracture

Exclusion criteria

a. Aged below 18 years old or above 60 years old (based on SOCSO scheme) b. Multiple limbs or bodily fractures in addition to wrist fracture c. Carpal bone involvement d. Associated peripheral nerve or/and tendon injuries to the affected upper limb e. Associated neurological conditions related to the central nervous system f. Cognitive impairment or psychiatric condition g. Severe and uncontrolled medical conditions e.g. cardiovascular disorders, respiratory disorders, cancer h. Cardiac pacemaker i. Skin disorders e.g. eczema, psoriasis, open would etc. of the affected forearm and hand that prevent electrode placements j. Severe contracture of the affected wrist joint k. Forearm size that is not fit to wear the Single Joint Hybrid Assistive Limb (HAL-SJ) robotic exoskeleton

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026