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.