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Evaluation eines mechanischen arm-trainers im rahmen einer einfach verblindeten, randomisierten studie (A mechanical arm trainer for the treatment of the severely affected arm after stroke: a single-blinded randomized trial in two centres) [German]
Hesse S, Werner C, Pohl M, Holzgraefe M, Mehrholz J, Puzich U, Drust A
Neurologie und Rehabilitation 2008 Dec;14(6):307-314
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To evaluate a mechanical arm trainer (AT) in stroke patients with severe upper limb paresis. It enables the bilateral practice of a 3 degree-of-freedom movement. Control patients received paretic wrist electrical stimulation (ES). DESIGN: Randomized controlled trial. SETTING: In-patient rehabilitation units. PATIENTS: 54 patients, stroke interval 4 to 8 weeks, Fugl-Meyer Motor Score (FM 0 to 66) < 18, randomly assigned to two groups. INTERVENTIONS: AT- and ES-patients additionally practised 20 min every workday for 6 weeks. MAIN OUTCOME MEASURES: Primary measure was the FM (0 to 66), secondary was the Box and Block test, blindly assessed at T-begin, T-end and T-follow-up. RESULTS: Both groups were homogeneous at T-begin. Shoulder pain occurred in two AT-patients. The FM improved in both groups over time (p < 0.001), changes did not differ between groups. Significantly, more AT-patients reached the chosen criterion of a minimum of 3 blocks transported at Tend (5 versus 0, p = 0.023), at follow-up the responder rate (8 versus 4) did not differ. Most responders were "good candidates", with an initial FM > 10 and a fast restoration of gait and ADL-competence. At follow-up, muscle tone was significantly higher in the ES group (p < 0.018). CONCLUSION: The FM changes did not differ between groups. "Good candidates" profited significantly more from the AT on the secondary disability level, probably due to a higher repetition rate.

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