Skip to main content
. 2015 Nov 7;2015(11):CD006876. doi: 10.1002/14651858.CD006876.pub4

Timmermans 2014

Methods RCT
Method of randomisation: blocked randomisation, using opaque envelopes
Participants Country: the Netherlands
Sample size: 22
Inclusion criteria: first‐ever stroke, age between 18 and 85 years, clinically diagnosed with a central paresis of the arm/hand (strength: MRC grade 2 to 4 at entry into study), poststroke time ≥ 12 months, fair to good cognitive level (Mini‐Mental State Examination score ≥ 26), able to read and understand the Dutch language, unable to fully perform at least 2 of the following skills: drinking from a cup, eating with knife and fork, taking money from a purse and using a tray, motivated to train at least 2 of the above‐mentioned skills.
(At the start of the last 6 months of the inclusion period, inclusion criteria were adjusted to poststroke time ≥ 8 months, to facilitate participant inclusion)
Exclusion criteria: severe neglect (Bell Test, Letter Cancellation Test: minimum omission score of 15%), hemianopsia, severe spasticity (MAS total arm > 3, severe additional neurological, orthopaedic, or rheumatoid impairments prior to stroke that could interfere with task performance, Broca's aphasia, Wernicke's aphasia, global aphasia (determined by the Akense Afasie Test), apraxia (apraxia test of Van Heugten), and attending another study or therapy to improve arm‐hand function
Interventions 2 groups:
  1. robotic‐assisted training with the end‐effector robot HapticMaster

  2. arm‐hand training program (control group)


Training was provided during 8 weeks, 4 times/week, twice a day for 30 minutes (separated by 0.5 hour to 1 hour of rest)
Outcomes Outcomes were recorded at baseline and post‐treatment every 2 weeks
  • FMA

  • ARAT

  • MAL (quality of use (QU) and amount of use (AU))

  • EuroQol‐5D (visual analogue scale)

  • SF‐36

Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "participants were randomly allocated to ... using blocked randomization (block size = 2). The randomization procedure was performed by an independent researcher using 2 opaque envelopes with in each envelope a training condition code."
Allocation concealment (selection bias) Low risk Quote: "The randomization procedure was performed by an independent researcher using 2 opaque envelopes within each envelope a training condition code."
Blinding of outcome assessment (detection bias) All outcomes Low risk Quote: "Persons involved in data collection were blinded for group allocation."
Selective reporting (reporting bias) Unclear risk Insufficient information to permit judgement