Robot-Enhanced Stroke Therapy Optimizes Rehabilitation (RESTORE)

NCT04201613 | Unknown

• 1 other identifier: REB13-0414
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate two aspects of robotic therapy after stroke. One goal is to determine if early robotic rehabilitation of the upper limb (beginning 5-9 days post-stroke) is more effective than later robotic rehabilitation (beginning 21-25 days post-stroke). The other goal is to determine if higher intensity robotic rehabilitation (2 hours/day) is more effective than lower intensity robotic rehabilitation (1 hour/day).

Conditions

Stroke

Keywords

Stroke; Stroke Rehabilitation; Robotic Exoskeleton

Outcome Measures

Primary Outcomes (1)

• Change in Fugl-Meyer upper extremity motor function score (FMA)

  FMA scores upper extremity motor impairment based on 22 items and scores range from 0 (completely plegic) to 66 (normal).

  From baseline to 44 days

Secondary Outcomes (4)

• Functional Independence Measure (FIM)

  From baseline to 180 days

• modified Rankin Scale (mRS)

  From baseline to 180 days

• Action Research Arm Test (ARAT)

  From baseline to 180 days

• Robotic Assessments

  From baseline to 180 days.

Study Arms (5)

Early Robotic Rehab Low Intensity

ACTIVE COMPARATOR

This group will begin robotic rehabilitation using a robotic exoskeleton between days 5-9 after their stroke. They will receive one hour of treatment per day for 20 days.

Device: Robotic exoskeleton

Early Robotic Rehab High Intensity

ACTIVE COMPARATOR

This group will begin robotic rehabilitation using a robotic exoskeleton between days 5-9 after their stroke. They will receive 2 one-hour treatment sessions per day for 20 days.

Device: Robotic exoskeleton

Late Robotic Rehab Low Intensity

ACTIVE COMPARATOR

This group will begin robotic rehabilitation using a robotic exoskeleton between days 21-25 after their stroke. They will receive one hour of treatment per day for 20 days.

Device: Robotic exoskeleton

Late Robotic Rehab High Intensity

ACTIVE COMPARATOR

This group will begin robotic rehabilitation using a robotic exoskeleton between days 21-25 after their stroke. They will receive 2 one-hour treatment sessions per day for 20 days.

Device: Robotic exoskeleton

Control Group

ACTIVE COMPARATOR

This group will receive usual care with robotic assessment.

Behavioral: Usual Care

Interventions

Robotic exoskeleton DEVICE

The Kinesiological Instrument for Normal and Altered Reaching Movements (KINARM) robotic exoskeleton used to provide therapy and assessment. The device has framework that supports the arms and the supports are adjustable to ensure a comfortable fit. Motors attached to the framework record shoulder and elbow movements and also move the arms.

Also known as: KINARM

Early Robotic Rehab High Intensity; Early Robotic Rehab Low Intensity; Late Robotic Rehab High Intensity; Late Robotic Rehab Low Intensity

Usual Care BEHAVIORAL

This group will receive standard care with no additional therapy.

Control Group

Eligibility Criteria

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

You may qualify if:

• Recent first stroke (ischemic or hemorrhagic)
• Upper extremity Fugl-Meyer score 15-45
• Modified Ashworth score of shoulder/elbow less than or equal to 2
• Able to follow task instructions
• Visual acuity better than 20/50 in both eyes
• Able to give consent
• Able to commit to follow-up

You may not qualify if:

• Prior stroke or significant neurologic problem (e.g. Multiple Sclerosis)
• Pre-existing musculoskeletal injury that will interfere with active therapy
• Pre-Stroke Modified Rankin Score \> 2
• Clinical evidence of Unilateral Spatial Neglect on the Behavioural Inattention Test (BIT)
• Enrollment in a concurrent clinical intervention trial
• Major co-morbid or concurrent illness such that improvement is unlikely or completion of the protocol as specified is unlikely

Sponsors & Collaborators

• University of Calgary: lead
• Queen's University: collaborator

Study Sites (1)

Foothills Hospital

Calgary, Alberta, T2N2T9, Canada

RECRUITING

Related Publications (14)

• Volpe BT, Krebs HI, Hogan N, Edelstein OTR L, Diels C, Aisen M. A novel approach to stroke rehabilitation: robot-aided sensorimotor stimulation. Neurology. 2000 May 23;54(10):1938-44. doi: 10.1212/wnl.54.10.1938.

  PMID: 10822433 BACKGROUND

• Fasoli SE, Krebs HI, Stein J, Frontera WR, Hogan N. Effects of robotic therapy on motor impairment and recovery in chronic stroke. Arch Phys Med Rehabil. 2003 Apr;84(4):477-82. doi: 10.1053/apmr.2003.50110.

  PMID: 12690583 BACKGROUND

• Dukelow SP, Herter TM, Moore KD, Demers MJ, Glasgow JI, Bagg SD, Norman KE, Scott SH. Quantitative assessment of limb position sense following stroke. Neurorehabil Neural Repair. 2010 Feb;24(2):178-87. doi: 10.1177/1545968309345267. Epub 2009 Sep 30.

  PMID: 19794134 BACKGROUND

• Ferraro M, Palazzolo JJ, Krol J, Krebs HI, Hogan N, Volpe BT. Robot-aided sensorimotor arm training improves outcome in patients with chronic stroke. Neurology. 2003 Dec 9;61(11):1604-7. doi: 10.1212/01.wnl.0000095963.00970.68.

  PMID: 14663051 BACKGROUND

• Daly JJ, Hogan N, Perepezko EM, Krebs HI, Rogers JM, Goyal KS, Dohring ME, Fredrickson E, Nethery J, Ruff RL. Response to upper-limb robotics and functional neuromuscular stimulation following stroke. J Rehabil Res Dev. 2005 Nov-Dec;42(6):723-36. doi: 10.1682/jrrd.2005.02.0048.

  PMID: 16680610 BACKGROUND

• Finley MA, Fasoli SE, Dipietro L, Ohlhoff J, Macclellan L, Meister C, Whitall J, Macko R, Bever CT Jr, Krebs HI, Hogan N. Short-duration robotic therapy in stroke patients with severe upper-limb motor impairment. J Rehabil Res Dev. 2005 Sep-Oct;42(5):683-92. doi: 10.1682/jrrd.2004.12.0153.

  PMID: 16586194 BACKGROUND

• Volpe BT, Lynch D, Rykman-Berland A, Ferraro M, Galgano M, Hogan N, Krebs HI. Intensive sensorimotor arm training mediated by therapist or robot improves hemiparesis in patients with chronic stroke. Neurorehabil Neural Repair. 2008 May-Jun;22(3):305-10. doi: 10.1177/1545968307311102. Epub 2008 Jan 9.

  PMID: 18184932 BACKGROUND

• Lo AC, Guarino PD, Richards LG, Haselkorn JK, Wittenberg GF, Federman DG, Ringer RJ, Wagner TH, Krebs HI, Volpe BT, Bever CT Jr, Bravata DM, Duncan PW, Corn BH, Maffucci AD, Nadeau SE, Conroy SS, Powell JM, Huang GD, Peduzzi P. Robot-assisted therapy for long-term upper-limb impairment after stroke. N Engl J Med. 2010 May 13;362(19):1772-83. doi: 10.1056/NEJMoa0911341. Epub 2010 Apr 16.

  PMID: 20400552 BACKGROUND

• Liao WW, Wu CY, Hsieh YW, Lin KC, Chang WY. Effects of robot-assisted upper limb rehabilitation on daily function and real-world arm activity in patients with chronic stroke: a randomized controlled trial. Clin Rehabil. 2012 Feb;26(2):111-20. doi: 10.1177/0269215511416383. Epub 2011 Aug 12.

  PMID: 21840917 BACKGROUND

• Cumming TB, Thrift AG, Collier JM, Churilov L, Dewey HM, Donnan GA, Bernhardt J. Very early mobilization after stroke fast-tracks return to walking: further results from the phase II AVERT randomized controlled trial. Stroke. 2011 Jan;42(1):153-8. doi: 10.1161/STROKEAHA.110.594598. Epub 2010 Dec 9.

  PMID: 21148439 BACKGROUND

• Hu MH, Hsu SS, Yip PK, Jeng JS, Wang YH. Early and intensive rehabilitation predicts good functional outcomes in patients admitted to the stroke intensive care unit. Disabil Rehabil. 2010;32(15):1251-9. doi: 10.3109/09638280903464448.

  PMID: 20131942 BACKGROUND

• Scott SH, Dukelow SP. Potential of robots as next-generation technology for clinical assessment of neurological disorders and upper-limb therapy. J Rehabil Res Dev. 2011;48(4):335-53. doi: 10.1682/jrrd.2010.04.0057.

  PMID: 21674387 BACKGROUND

• Semrau JA, Herter TM, Scott SH, Dukelow SP. Robotic identification of kinesthetic deficits after stroke. Stroke. 2013 Dec;44(12):3414-21. doi: 10.1161/STROKEAHA.113.002058. Epub 2013 Nov 5.

  PMID: 24193800 BACKGROUND

• Keeling AB, Piitz M, Semrau JA, Hill MD, Scott SH, Dukelow SP. Robot enhanced stroke therapy optimizes rehabilitation (RESTORE): a pilot study. J Neuroeng Rehabil. 2021 Jan 21;18(1):10. doi: 10.1186/s12984-021-00804-8.

  PMID: 33478563 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Exoskeleton Device

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Sean Dukelow, MD, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark Piitz, BSc

CONTACT

403-944-4050; mark.piitz@albertahealthservices.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 17, 2019
• Study Start: May 1, 2019
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2023
• Last Updated: December 23, 2019

Record last verified: 2019-12

Locations

CA (1)