StrokeRESTORENCT04201613
Robot-Enhanced Stroke Therapy Optimizes Rehabilitation (RESTORE)
A study testing Robotic exoskeleton in people with Stroke, run by University of Calgary at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Robotic exoskeleton
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2019to Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Foothills Hospital
Calgary, Alberta, T2N2T9
Sean Dukelow, MD PhD, 4039445930, spdukelo@ucalgary.ca
About this study
Official title: Robot-Enhanced Stroke Therapy Optimized Rehabilitation
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).
Read the detailed description
Medically stable stroke subjects will be recruited in the first few days following their stroke. All participants will complete clinical and robotic assessments of neurologic function at 7 time points. Therapy will occur daily (Monday through Friday) for 20 days.
Study participants will be randomly assigned to 1) start robot therapy early or late after stroke and 2)receive one or two hours of robot therapy per treatment day for four weeks, or 3) control group that will receive the current standard of care.
The participant's chart will be reviewed for information about their stroke and related health effects and medical treatments. Assessment points to track progress will occur at 7, 18, 31,44,90,180, and 365 days after a stroke for all groups (give or take 2 days to account for weekends and holidays).
Standard clinical assessments of neurologic function will be done at each assessment point and include: cognition, arm strength, muscle tone, spasticity, reflexes, dexterity, visual acuity and fields, the Behavioural Inattention Test, and tests of arm movement (Fugl-Meyer Upper-Extremity, Box and Block Test, Chedoke-McMaster Stroke Assessment, and the Action Research Arm Test). These assessments can usually be done in about an hour. The assessment may be done over two sessions if needed due to fatigue or scheduling conflicts.
Robotic therapy will be conducted using the Kinesiological Instrument for Normal and Altered Reaching Movements (KINARM, Bkin Technologies, Kingston, ON). It will include several different tasks, each designed to train aspects of sensorimotor function of the proximal upper limb. Task performance will be monitored and difficulty will increase within and between sessions. The majority of the investigator's methods have been used previously to achieve equivalent or superior outcomes to standard rehabilitation.
Robotic assessment will measure elbow and shoulder range of motion, reaching for targets, the ability to mirror match the position of an arm with the other arm, and the ability to use both arms to hit away moving targets. The robotic assessment will take approximately 1.5 hours.
Robotic tasks include:
Visually guided reaching with assistance or resistance; Virtual Soccer; Shape Tracking; Whack-a-mole; Table Tennis Task; Ball on Bar Task; Proprioceptive Reaching; Hand Ball; Proprioceptive Shape Tracking.
- Conditions
- Stroke
- Being tested
- Robotic exoskeleton, Usual Care
- Keywords
- Stroke, Stroke Rehabilitation, Robotic Exoskeleton
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic exoskeletonDevice
Also called KINARM
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.
Usual CareBehavioural
This group will receive standard care with no additional therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Robotic exoskeleton |
| Control Group | Active comparator | This group will receive usual care with robotic assessment. Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From baseline to 44 days
Secondary outcomes (4)
Functional Independence Measure (FIM)
FIM rates subjects on 18 items across many functions such as eating, grooming, bathing and dressing on a scale from 1 (total assistance needed) to 7 (complete independence). Lowest possible score is 18 (lowest independence) and the best possible score is 126 (completely independent). The FIM is the standard measure used by rehabilitation facilities in Cananda and the United States to evaluate overall function and burden of care.
Measured: From baseline to 180 days
modified Rankin Scale (mRS)
The mRS is a disability rating scale from 0 (no symptoms at all) to 6 (deceased).
Measured: From baseline to 180 days
Action Research Arm Test (ARAT)
The ARAT assesses arm function to determine the quality of the arm movement, and the limitation of activity. The ARAT consists of 4 sub-tests; that examines and individual's grip, grasp, pinch and gross motor movement in order to determine upper extremity function. Objects of varying size, shape, and weight must be either grasped, handled or moved in a specific task in order to evaluate function. Low scores mean worse function with the minimum possible score being 0 and the highest possible score being 57 (normal function).
Measured: From baseline to 180 days
Robotic Assessments
Robotic Assessments. The robotic assessment consists of a number of upper limb tests of neurologic function which have been validated against standard clinical measures. Tasks include: Range of Motion, Visually Guided Reaching, Limb Position Matching, Limb Kinesthesia, and Object Hit. These assessments use z-scores, based on normal distributions, as a measure of performance. Scores within 1.96 standard deviations away from 0 are considered normal and scores beyond 1.96 standard deviations are considered impaired.
Measured: From baseline to 180 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start1 May 2019
- Primary completionOct 2022 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's University
- Responsible party
- Principal investigator, Dr. Sean Dukelow, University of Calgary
- Investigators
- Sean Dukelow, MD, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201613
- Sponsor's protocol ID
- REB13-0414
- Acronym
- RESTORE
- Status last verified
- Dec 2019
- First submitted
- 13 Dec 2019
- Last updated
- 23 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 10822433Fasoli 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.
PubMed 12690583Dukelow 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.
PubMed 19794134Ferraro 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.
PubMed 14663051Daly 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.
PubMed 16680610Finley 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.
PubMed 16586194Volpe 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.
PubMed 18184932Lo 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.
PubMed 20400552Liao 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.
PubMed 21840917Cumming 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.
PubMed 21148439Hu 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.
PubMed 20131942Scott 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.
PubMed 21674387Semrau 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.
PubMed 24193800Keeling 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.
PubMed 33478563
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-Enhanced Stroke Therapy Optimized Rehabilitation
- ClinicalTrials.gov ID
- NCT04201613
- Acronym / sponsor ID
- RESTORE / REB13-0414
- Conditions
- Stroke
- Keywords
- Stroke, Stroke Rehabilitation, Robotic Exoskeleton
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Queen's University
- Study start
- 1 May 2019 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 17 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Medically stable stroke subjects will be recruited in the first few days following their stroke. All participants will complete clinical and robotic assessments of neurologic function at 7 time points. Therapy will occur daily (Monday through Friday) for 20 days.
Study participants will be randomly assigned to 1) start robot therapy early or late after stroke and 2)receive one or two hours of robot therapy per treatment day for four weeks, or 3) control group that will receive the current standard of care.
The participant's chart will be reviewed for information about their stroke and related health effects and medical treatments. Assessment points to track progress will occur at 7, 18, 31,44,90,180, and 365 days after a stroke for all groups (give or take 2 days to account for weekends and holidays).
Standard clinical assessments of neurologic function will be done at each assessment point and include: cognition, arm strength, muscle tone, spasticity, reflexes, dexterity, visual acuity and fields, the Behavioural Inattention Test, and tests of arm movement (Fugl-Meyer Upper-Extremity, Box and Block Test, Chedoke-McMaster Stroke Assessment, and the Action Research Arm Test). These assessments can usually be done in about an hour. The assessment may be done over two sessions if needed due to fatigue or scheduling conflicts.
Robotic therapy will be conducted using the Kinesiological Instrument for Normal and Altered Reaching Movements (KINARM, Bkin Technologies, Kingston, ON). It will include several different tasks, each designed to train aspects of sensorimotor function of the proximal upper limb. Task performance will be monitored and difficulty will increase within and between sessions. The majority of the investigator's methods have been used previously to achieve equivalent or superior outcomes to standard rehabilitation.
Robotic assessment will measure elbow and shoulder range of motion, reaching for targets, the ability to mirror match the position of an arm with the other arm, and the ability to use both arms to hit away moving targets. The robotic assessment will take approximately 1.5 hours.
Robotic tasks include:
Visually guided reaching with assistance or resistance; Virtual Soccer; Shape Tracking; Whack-a-mole; Table Tennis Task; Ball on Bar Task; Proprioceptive Reaching; Hand Ball; Proprioceptive Shape Tracking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Early Robotic Rehab Low Intensity | Active comparator | Device: Robotic exoskeletonThis 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. |
| Early Robotic Rehab High Intensity | Active comparator | Device: Robotic exoskeletonThis 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. |
| Late Robotic Rehab Low Intensity | Active comparator | Device: Robotic exoskeletonThis 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. |
| Late Robotic Rehab High Intensity | Active comparator | Device: Robotic exoskeletonThis 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. |
| Control Group | Active comparator | Behavioral: Usual CareThis group will receive usual care with robotic assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic exoskeletonAlso: KINARMThe 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. | Device | Early Robotic Rehab High Intensity, Early Robotic Rehab Low Intensity, Late Robotic Rehab High Intensity, Late Robotic Rehab Low Intensity |
| Usual CareThis group will receive standard care with no additional therapy. | Behavioural | Control Group |
Primary outcome
Change in Fugl-Meyer upper extremity motor function score (FMA)
Time frame: From baseline to 44 days
FMA scores upper extremity motor impairment based on 22 items and scores range from 0 (completely plegic) to 66 (normal).
4 secondary outcomes
Functional Independence Measure (FIM)
Time frame: From baseline to 180 days
modified Rankin Scale (mRS)
Time frame: From baseline to 180 days
Action Research Arm Test (ARAT)
Time frame: From baseline to 180 days
Robotic Assessments
Time frame: From baseline to 180 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2019.
- Background: PubMed 10822433Volpe 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.
- Background: PubMed 12690583Fasoli 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.
- Background: PubMed 19794134Dukelow 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.
- Background: PubMed 14663051Ferraro 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.
- Background: PubMed 16680610Daly 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.
- Background: PubMed 16586194Finley 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.
- Background: PubMed 18184932Volpe 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.
- Background: PubMed 20400552Lo 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.
- Background: PubMed 21840917Liao 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.
- Background: PubMed 21148439Cumming 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.
- Background: PubMed 20131942Hu 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.
- Background: PubMed 21674387Scott 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Dukelow, MD, PhD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic exoskeleton in people with Stroke, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Piitz, BSc (403-944-4050, mark.piitz@albertahealthservices.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fugl-Meyer upper extremity motor function score (FMA) (time frame: From baseline to 44 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04201613, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2019.