Effectiveness of combined modified constraint-induced movement therapy for upper and lower limb in stroke rehabilitation: a study protocol for randomized controlled trial (Preprint)
Authors: Umar Lawan 
Published: February 2018

BACKGROUND

Background: The translation of neuroscientific research into care has led to new approaches and renewed promise. Stroke survivors with hemiparesis often exhibit impaired balance, ambulation dysfunction and asymmetrical weight distribution leading to physical dysfunction and decreased Health-Related Quality of Life (HRQoL).Constraint-induced movement therapy (CIMT) approach could be translated into a clinical protocol for gait rehabilitation. Modified CIMT for upper limb and lower limb when applied singly improve lower limb motor function, balance, gait and HRQoL of stroke survivors

OBJECTIVE

However, effects of combined modified CIMT for upper and lower limbs (CoMCIMTULL) have not been investigated. Therefore, the effects of four-week CoMCIMTULL was compared with Modified CIMT Lower Limb (MCIMTLL) and Modified CIMT Upper Limb (MCIMTUL) among hemiparetic stroke survivors in this study.

METHODS

This single-blind randomized controlled trial involved random assignment of 56 consecutive stroke survivors to three groups: CoMCIMTULL (n=19), MCIMTLL (n=20), and MCIMTUL (n=17). The CoMCIMTULL group received both upper and lower limb CIMT for the reduced use of the upper limb and maladaptive use of the lower limb. The MCIMTLL group used the affected lower limb to lead weight bearing activities and exercises while the MCIMTUL group used the affected upper limbs for motor task practice following the unaffected hand’s restraining in a special splint. These treatments were administared in the clinic for two hours daily, five times per week for four consecutive weeks. Lower Limb Motor Function (LLMF) and balance were assessed using Fugyl Meyer Motor Assessement Scale, Lower Limb Use (LLU) with Lower Extremity Motor Activity Log, balance confidence using Activities-specific Balance Confidence Scale, Weight Asymmetry Ratio (WAR) using two weighing scales, spatiotemporal gait parameters [gait speed (m/s) and stride length (m)] using foot print method and HRQoL using the Stroke Impact Scale. These assessments were done at baseline, ends of weeks two and four. Data were analysed using descriptive statistics, ANOVA with post-hoc, Kruskal-Wallis with post-hoc and Wilcoxon Signed Rank at ᾳ0.05.

RESULTS

MBetween-group comparisons showed that the differences were significant in CoMCIMTULL (HRQoL score=70.00(10.00) ; LLMF = 29.00(5.00); gait speed=0.650(0.70)m/s ; Stride length=0.60(0.30)m ; and WAR=0.90(0.80) ) compared to MCIMTLL (HRQoL score=80.00(17.50); LLMF =29.50(2.50) ; gait speed=0.80(0.28)m/s; Stride length=0.65(0.40)m; and WAR=0.85(0.40) and MCIMTUL (HRQoL score= 60.00(10.00; LLMF =26.00(4.00) ; gait speed= 0.60(0.20)m/s;Stride length= 0.40(0.40)m; and WAR= 0.80(0.40)

CONCLUSIONS

It is expected, the outcome of this study will clarify whether the effect of combined modified CIMT upper and lower limb (CoMCIMTULL), Modified CIMT Lower Limb (MCIMTLL) and Modified CIMT Upper Limb (MCIMTUL) will leads to better recovery of motor function in stroke survivors.

CLINICALTRIAL

This study has been approved by both Health Research Ethics Committee of Universty of Ibadan/University College Hospital (UI/EC/14/0101) and the Murtala Muhammad Specialist Hospital, Kano (HMB/GEN/488/VOL.I)(Nigeria). Additionaly, the study employed a randomized controlled clinical trial design, registered with Pan Africa Clinical Trial Registry PACTR 201611001646207, available on www.pactr.org.