Robot assisted training for the upper limb after stroke

Phase 3

Completed

• Conditions: Stroke rehabilitation; Circulatory System

• Registration Number: ISRCTN69371850
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Brief Summary

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28728602 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31128926 (added 29/05/2019) 2021 economic evaluation results in https://pubmed.ncbi.nlm.nih.gov/34035087/ (added 27/05/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-04
• Study Completion: 2019-08-31
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 770

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pper limb function measured using the Action Research Arm Test (ARAT) at 3 months post randomisation

Secondary Outcome Measures

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