Therefore, the research questions for this trial were:
1. Could the use of an orthosis, such as the Saebo Glove, to enhance the function of the affected limb facilitate the clinical implementation of CIMT?
2. If patients benefit from the assistive orthosis, could the Saebo Glove optimise the constraint time and inclusion criteria for CIMT?
This study was divided into two parts. Part A ( mCIMT+Saebo and mCIMT group) involved patients eligible for mCIMT, comparing the differences in efficacy and emotional changes when combined with the Saebo Glove. Part B (mCIMT+Saebo and control group) observed the implementation of CIMT with the assistance of Saebo Glove in patients not eligible for mCIMT. Both parts were assessor-blinded, two-arm, parallel-group randomised 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 Saebo Glove and a mitt for the same duration.
Primary outcome measure was WMFT (included hand grip strength), MAL, ARAT. Secondary Outcomes included surface electromyography (sEMG) of wrist extensor muscles, MTS, TSS, MEP, HAMA and HAMD.
Part A: After 3 weeks treatment, the primary outcome WMFT showed that mCIMT+Saebo group scored 7.23 points higher (95% CI 1.93 to 12.53) than mCIMT group. Hand grip strength, one of the WMFT strength items, scored 3.29 points higher (95% CI 1.35 to 5.24) than in the mCIMT group.
Part B: After 3 weeks treatment, the primary outcome WMFT showed that mCIMT+Saebo group scored 5.45 points higher (95% CI 1.92 to 8.98) than the control group. Hand grip strength was 2.66 points higher (95% CI 1.33 to 3.99), and ARAT was 10.75 points (95% CI 0.93 to 20.57) higher than in the control group.
The orthosis may enhance the therapeutic advantages of mCIMT and broaden the inclusion criteria for CIMT.
The findings from this study may encourage greater use of suitable orthoses for the affected upper limb in daily life activities.
Constraint-Induced Movement Therapy
Wrist-hand orthosis