How to design clinical rehabilitation trials for the upper paretic limb early post stroke?

Trials

Volumn 17, Issue 1, 2016, Pages

  Winters, Caroline ^a,b   Heymans, Martijn W ^a,b   van Wegen, Erwin E H ^a,b   Kwakkel, Gert ^a,b,c,d  

^a VU UNIVERSITY MEDICAL CENTER   (Netherlands)

^b VU UNIVERSITY AMSTERDAM   (Netherlands)

^c Amsterdam Rehabilitation Research Center Reade   (Netherlands)

^d NORTHWESTERN UNIVERSITY   (United States)

Author keywords

Power; Prognostic stratification; Randomized controlled trial; Sample size; Stroke; Upper extremity

Indexed keywords

ADULT; ANALYTICAL ERROR; ARM EXERCISE; ARM MOVEMENT; ARTICLE; CEREBROVASCULAR ACCIDENT; COHORT ANALYSIS; CONVALESCENCE; FEMALE; FINGER; FUGL MEYER ASSESSMENT; HUMAN; MAJOR CLINICAL STUDY; MALE; METHODOLOGY; MIDDLE AGED; NEUROLOGIC DISEASE ASSESSMENT; PATIENT SELECTION; PROGNOSIS; RANDOM SAMPLE; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); SAMPLE SIZE; STRATIFIED SAMPLE; TREATMENT OUTCOME;

EID: 84988884727     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-016-1592-x     Document Type: Article

References (34)

1. Veerbeek JM, van Wegen, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, et al. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014;9:e87987.
2. Pollock A, Farmer SE, Brady MC, Langhorne P, Mead GE, Mehrholz J, et al. Interventions for improving upper limb function after stroke. Cochrane Database Syst Rev. 2014;11, CD010820.
3. Murphy TH, Corbett D. Plasticity during stroke recovery: from synapse to behaviour. Nat Rev Neurosci. 2009;10:861-72.
4. Krakauer JW, Carmichael ST, Corbett D, Wittenberg GF. Getting neurorehabilitation right: what can be learned from animal models? Neurorehabil Neural Repair. 2012;26:923-31.
5. Carmichael ST, Krakauer JW. The promise of neuro-recovery after stroke: introduction. Stroke. 2013;44:S103.
6. Duncan PW, Goldstein LB, Matchar D, Divine GW, Feussner J. Measurement of motor recovery after stroke. Outcome assessment and sample size requirements. Stroke. 1992;23:1084-9.
7. Kwakkel G, Kollen B, Twisk J. Impact of time on improvement of outcome after stroke. Stroke. 2006;37:2348-53.
8. Cramer SC. Repairing the human brain after stroke: I. Mechanisms of spontaneous recovery. Ann Neurol. 2008;63:272-87.
9. Nijboer TC, Kollen BJ, Kwakkel G. The impact of recovery of visuo-spatial neglect on motor recovery of the upper paretic limb after stroke. PLoS One. 2014;9, e100584.
10. Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011;377:1693-702.
11. Langhorne P, Coupar F, Pollock A. Motor recovery after stroke: a systematic review. Lancet Neurol. 2009;8:741-54.
12. Nijland RH, van Wegen EE, Harmeling-van der Wel BC, Kwakkel G. Presence of finger extension and shoulder abduction within 72 hours after stroke predicts functional recovery: early prediction of functional outcome after stroke: the EPOS cohort study. Stroke. 2010;41:745-50.
13. Stinear C. Prediction of recovery of motor function after stroke. Lancet Neurol. 2010;9:1228-32.
14. Byblow WD, Stinear CM, Barber PA, Petoe MA, Ackerley SJ. Proportional recovery after stroke depends on corticomotor integrity. Ann Neurol. 2015;78:848-59.
15. Sunderland A, Tinson DJ, Bradley EL, Fletcher D, Langton HR, Wade DT. Enhanced physical therapy improves recovery of arm function after stroke. A randomised controlled trial. J Neurol Neurosurg Psychiatry. 1992;55:530-5.
16. Kwakkel G, Winters C, van Wegen EE, Nijland RH, van Kuijk AA, Visser-Meily A, et al. Effects of unilateral upper limb training in two distinct prognostic groups early after stroke: the EXPLICIT-stroke randomized clinical trial. Neurorehabil Neural Repair. 2016. [Epub ahead of print 7 Jan 2016].
17. Kwakkel G, Veerbeek JM, van Wegen EE, Wolf SL. Constraint-induced movement therapy after stroke. Lancet Neurol. 2015;14:224-34.
18. Jolkkonen J, Kwakkel G. Translational hurdles in stroke recovery studies. Transl Stroke Res. 2016. [Epub ahead of print 22 Mar 2016].
19. Kwakkel G, Meskers CG, van Wegen EE, Lankhorst GJ, Geurts AC, van Kuijk AA, et al. Impact of early applied upper limb stimulation: the EXPLICIT-stroke programme design. BMC Neurol. 2008;8:49.
20. Lyle RC. A performance test for assessment of upper limb function in physical rehabilitation treatment and research. Int J Rehabil Res. 1981;4:483-92.
21. Yozbatiran N, Der-Yeghiaian L, Cramer SC. A standardized approach to performing the action research arm test. Neurorehabil Neural Repair. 2008;22:78-90.
22. Van der Lee JH, Wagenaar RC, Lankhorst GJ, Vogelaar TW, Deville WL, Bouter LM. Forced use of the upper extremity in chronic stroke patients: results from a single-blind randomized clinical trial. Stroke. 1999;30:2369-75.
23. Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7:13-31.
24. Sanford J, Moreland J, Swanson LR, Stratford PW, Gowland C. Reliability of the Fugl-Meyer assessment for testing motor performance in patients following stroke. Phys Ther. 1993;73:447-54.
25. Van der Lee JH, Beckerman H, Lankhorst GJ, Bouter LM. The responsiveness of the Action Research Arm test and the Fugl-Meyer Assessment scale in chronic stroke patients. J Rehabil Med. 2001;33:110-3.
26. Gladstone DJ, Danells CJ, Black SE. The Fugl-Meyer assessment of motor recovery after stroke: a critical review of its measurement properties. Neurorehabil Neural Repair. 2002;16:232-40.
27. Prabhakaran S, Zarahn E, Riley C, Speizer A, Chong JY, Lazar RM, et al. Inter-individual variability in the capacity for motor recovery after ischemic stroke. Neurorehabil Neural Repair. 2008;22:64-71.
28. Lazar RM, Minzer B, Antoniello D, Festa JR, Krakauer JW, Marshall RS. Improvement in aphasia scores after stroke is well predicted by initial severity. Stroke. 2010;41:1485-8.
29. Winters C, van Wegen EE, Daffertshofer A, Kwakkel G. Generalizability of the Proportional Recovery Model for the upper extremity after an ischemic stroke. Neurorehabil Neural Repair. 2015;29:614-22.
30. Krakauer JW, Marshall RS. The proportional recovery rule for stroke revisited. Ann Neurol. 2015;78:845-7.
31. Veerbeek JM, van Wegen EE, Harmeling-van der Wel BC, Kwakkel G. Is accurate prediction of gait in nonambulatory stroke patients possible within 72 hours poststroke? The EPOS study. Neurorehabil Neural Repair. 2011;25:268-74.
32. 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;34:2181-6.
33. Ali M, English C, Bernhardt J, Sunnerhagen KS, Brady M. More outcomes than trials: a call for consistent data collection across stroke rehabilitation trials. Int J Stroke. 2013;8:18-24.
34. Duncan PW. Outcome measures in stroke rehabilitation. Handb Clin Neurol. 2013;110:105-11.