The Efficacy of Additional Motor Training Dosage During the Early Stages Post Stroke on the Upper Extremity Recovery

Official title

Efficacy of High-dosage, High-intensity Rehabilitation Program on the Motor Recovery After Stroke in Subacute Patients

Overview

Intervention abstract Background: Stroke is the leading cause of long-term disability, and the second leading cause of death in the western world. Most stroke survivors will suffer from motor and cognitive disturbances for the rest of their life, which negatively affects their normal daily life. Despite the decline in stroke-related mortality over the past decades, the outcome of rehabilitation programs does not improve, and is predictable regardless of the program used. Still, several human and animal studies show that high capacity of training in the early stages post stroke improve motor recovery. This notion is far from being well established. Aim: Studying the effect of high-dosage, high-intensity training program in the subacute period on upper extremity motor recovery. Population: Stroke survivors. Study duration: 6 months. Study protocol: Participants will receive additional technology-based upper extremity training for 120 min/day, 5d/w, 4 weeks. They will be monitored pre and post training, and 6 months post-stroke. Outcome measures will include clinical, kinematic and adherence measures (see complete list in the protocol).

Interventions

• Behavioral High dosage, high intensity motor rehabilitation
  Participants will receive additional technology-based upper extremity training for 120 min/day, 5d/w, 4 weeks.

Primary outcome measures

• Fugl-Meyer upper extremity assessment (FM-UE) [Time frame: Enrollment, 1 month, 3 months, 6 months after enrollment]
• Action research arm test (ARAT) [Time frame: Enrollment, 1 month, 3 months, 6 months after enrollment]
• Stroke Impact Scale (SIS) hand domain, version 2.0 [Time frame: Enrollment, 1 month, 3 months, 6 months after enrollment]
• Kinematics [Time frame: Enrollment, 1 month, 3 months, 6 months]

Secondary outcome measures (6)

• Upper extremity activity [Time frame: Enrollment and 3 months.]
• Time on task [Time frame: The measure will be recorded every single practice session, twice a day, 5 days a week. Total Time on Task will be calculated at the end of the intervention period, approximately 4 weeks.]
• Attendance [Time frame: The measure will be recorded every single practice session, twice a day, 5 days a week. Total attendance will be calculated at the end of the intervention period, approximately after 4 weeks.]
• Visual Analogue Scale for pain [Time frame: The measure will be recorded before and after every single practice session, twice a day, 5 days a week. The mean pain level delta will be calculated at the end of the intervention period, approximately 4 weeks.]
• Rating of perceived exertion (RPE) [Time frame: The measure will be recorded every single practice session, twice a day, 5 days a week.]
• The Intrinsic Motivation Inventory (IMI) [Time frame: At the end of the intervention period for each participant (i.e. 4 weeks).]

Eligibility criteria

Inclusion criteria

• Age ≥18 years
• Ischemic or hemorrhagic stroke (hemispheric or brainstem) confirmed by CT or MRI
• First-ever stroke or previous stroke with no upper extremity weakness
• 1 week ≤ Time after stroke onset ≤ 6 weeks
• Active shoulder flexion of at least 20◦ and partial wrist and/or finger active movement
• Ability to provide inform consent

Exclusion criteria

• A painful shoulder limiting an active forward reach
• Severe spasticity or non-neural loss of range of motion
• Cognitive or communication impairments as determined by the clinical team Unstable medical conditions

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Israel · 2 centers

• Adi Negev-Nahalat Eran — Ofakim
• Adi Negev-Nahalat Eran — Ofakim

Publications

• Miller EL, Murray L, Richards L, Zorowitz RD, Bakas T, Clark P, Billinger SA; American Heart Association Council on Cardiovascular Nursing and the Stroke Council. Comprehensive overview of nursing and interdisciplinary rehabilitation care of the stroke patient: a scientific statement from the American Heart Association. Stroke. 2010 Oct;41(10):2402-48. doi: 10.1161/STR.0b013e3181e7512b. Epub 2010 PMID 20813995
• Kwakkel G, Kollen BJ, van der Grond J, Prevo AJ. Probability of regaining dexterity in the flaccid upper limb: impact of severity of paresis and time since onset in acute stroke. Stroke. 2003 Sep;34(9):2181-6. doi: 10.1161/01.STR.0000087172.16305.CD. Epub 2003 Aug 7. PMID 12907818
• Buch ER, Rizk S, Nicolo P, Cohen LG, Schnider A, Guggisberg AG. Predicting motor improvement after stroke with clinical assessment and diffusion tensor imaging. Neurology. 2016 May 17;86(20):1924-5. doi: 10.1212/WNL.0000000000002675. Epub 2016 Apr 29. No abstract available. PMID 27164664
• Biernaskie J, Chernenko G, Corbett D. Efficacy of rehabilitative experience declines with time after focal ischemic brain injury. J Neurosci. 2004 Feb 4;24(5):1245-54. doi: 10.1523/JNEUROSCI.3834-03.2004. PMID 14762143

Identifiers

NCT: NCT07056049 · NGV-24-0006

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗