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Robot assisted training for the upper limb after stroke

Robot Assisted Training for the Upper Limb after Stroke (RATULS): a randomised interventional phase III study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN69371850
Enrollment
720
Registered
2013-10-04
Start date
2014-04-01
Completion date
Unknown
Last updated
2021-06-07

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

Conditions

Stroke rehabilitation Circulatory System

Interventions

This is a three-group randomised controlled trial. Group 1: Robot-assisted training Robot-assisted training will use the InMotion robotic gym system which comprises th

Sponsors

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adults with a first ever stroke who fulfil the following criteria are eligible: 1. Age 18 years and over 2. Clinical diagnosis of stroke (cerebral infarction, primary intracerebral haemorrhage, subarachnoid haemorrhage) 3. Between one week and five years since stroke 4. Moderate to severe upper limb functional limitation (Action Research Arm Test (ARAT) score 0-39) due to stroke 5. Able to provide consent to take part in the study and to comply with the requirements of the protocol

Exclusion criteria

Exclusion criteria: 1. More than one stroke (patients with previous transient ischaemic attack (TIA) may be invited to participate) 2. Other current significant impairment of the upper limb affected by stroke e.g. fixed contracture, frozen shoulder, severe arthritis, recent fracture 3. Diagnosis likely to interfere with rehabilitation or outcome assessments e.g. registered blind 4. Previous use of the InMotion robotic gym system or other arm rehabilitation robot 5. Current participation in a rehabilitation trial evaluating upper limb rehabilitation after stroke 6. Previous enrolment in this study

Design outcomes

Primary

MeasureTime frame
Upper limb function measured using the Action Research Arm Test (ARAT) at 3 months post randomisation

Secondary

MeasureTime frame
1. Upper limb impairment, measured using the Fugl-Meyer Test (motor and sensory arm sections) 2. Activities of daily living (measured using the Barthel ADL Index), quality of life (measured using EQ-5D-5L) 3. Upper limb pain, measured using a numerical rating scale 4. Resource use, measured using an adaption of the Client Services Receipt Inventory 5. Adverse events, measured at 3 and 6 months post randomisation

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 9, 2026