Efficacy and Safety of Caregiver-Mediated Exercise in Post-stroke Rehabilitation.

Objective: To assess the efficacy and safety of our 4-week caregiver-mediated exercise (CME) in improving trunk control capacity, gait, and balance and in decreasing concerns about post-stroke falls when there is an increase in its efficacy.

Methods: Acute or subacute stroke survivors were assigned to either the trial group (n=35) or the control group (n=37). Changes in Modified Barthel Index (MBI), Functional Ambulation Categories (FAC), Berg Balance Scale (BBS), and Trunk Impairment Scale (TIS) scores at 4 weeks from baseline served as primary outcome measures. Correlations of primary outcome measures with changes in Fall Efficacy Scale-International (FES-I) scores at 4 weeks from baseline in the trial group served as secondary outcome measures. Treatment-emergent adverse events (TEAEs) served as safety outcome measures.

Results: There were significant differences in changes in MBI, FAC, BBS, TIS-T, TIS-D, TIS-C, and FES-I scores at 4 weeks from baseline between the two groups (all p<0.0001). There were no significant (p=0.0755) differences in changes in TIS-S scores at 4 weeks from baseline between the two groups. MBI, FAC, BBS, and TIS scores showed significantly inverse correlations with FES-I scores in patients receiving CME. There were no TEAEs in our series.

Conclusion: CME was effective and safe in improving the degree of independence, ambulation status, dynamic and static balance, trunk function, and concerns about post-stroke falls in stroke survivors.