Effect of a dynamic wrist-hand orthosis combined with modified constraint-induced movement therapy on upper limb and hand function in acute and sub-acute stroke patients: a randomized controlled trial

Background: Constraint-Induced Movement Therapy (CIMT) is a “rehabilitation strategy” supported by numerous basic studies. However, its clinical implementation is often limited by the poor ability of the affected limb. Objectives: To combine mCIMT plus a SaeboGlove for persons who would not normally qualify for mCIMT training. Methods: Part A: mCIMT+Saebo group (n = 18) and mCIMT group (n = 19). Part B: mCIMT+Saebo group (n = 10) and control group (n = 9). Both parts were assessor-blinded, two-arm, parallel-group randomized controlled trials. In addition to conventional rehabilitation therapy, all groups, except the control group, underwent mCIMT. The mCIMT group wore a mitt for approximately 4 hours per day, 5 days a week, for 3 consecutive weeks. The mCIMT+Saebo group wore both the SaeboGlove and a mitt for the same duration. Results: Part A: Wolf Motor Function Test (WMFT) showed that mCIMT+Saebo group scored 7.23 points higher (95% CI 1.93 to 12.53) than mCIMT group (P < 0.05). Hand grip strength (item 14 of WMFT) scored 3.29 points higher (95% CI 1.35 to 5.24) than in the mCIMT group (P < 0.01). Part B: The WMFT showed that mCIMT+Saebo group scored 5.45 points higher (95% CI 1.92 to 8.98) than the control group (P < 0.01). Hand grip strength was 2.66 points higher (95% CI 1.33 to 3.99) (P < 0.001), and ARAT was 10.75 points higher (95% CI 0.93 to 20.57) than in the control group (P < 0.05). Conclusions: The SaeboGlove may enhance the therapeutic advantages of mCIMT and expand the inclusion criteria for CIMT.