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Evaluation of independent versus integrated effects of reciprocal electrical stimulation and Botulinum Toxin-A on dynamic limits of postural stability and ankle kinematics in spastic diplegia: a single-blinded randomized trial [with consumer summary]
Elnaggar RK, Elbanna MF
European Journal of Physical and Rehabilitation Medicine 2019 Apr;55(2):241-249
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Combination of medical and physical therapy protocols are increasingly recommended for cerebral palsied children. However, the clinicians frequently choose between independent or integrated treatment delivery based on little empirical evidence. AIM: To analyze the independent versus the integrated effects of reciprocal electrical stimulation (RES) and Botulinum Toxin-A (BoNT-A) in terms of dynamic limits of postural stability and ankle kinematics in spastic diplegia. DESIGN: A single-blinded randomized trial. SETTING: Physical therapy laboratories and out-patient clinic and a tertiary local hospital. POPULATION: Sixty children with spastic diplegia were allocated to RES, BoNT, or Integrated RES+BoNT interventions (20 children for each group). METHODS: All children participated in a 60-minutes exercise program, three times/week for 12 successive weeks. Additionally, the RES group received reciprocal electrical stimulation of ankle dorsi and plantar flexors for 30 minutes before each exercise session, the BoNT group were injected by Botulinum Toxin-A to calf muscles one-week prior to commencing the exercise program, and the integrated RES+BoNT group received both interventions. Ankle joint kinematics (displacement angle at initial contact, maximum dorsiflexion-stance, and peak dorsiflexion-swing) and dynamic limits of postural stability (anterior/posterior (AP-LOS), medial/lateral (ML-LOS), and overall (O-LOS)) were assessed at entry and after intervention. RESULTS: Study groups were comparable with respect to all outcome measures at entry (p > 0.05). Compared to the independent effect of either RES or BoNT-A, the integrated RES+BoNT-A produced a preferable improvement of O-LOS, maximum dorsiflexion-stance, and peak dorsiflexion-swing subsequently after intervention (p < 0.05). Further, significant differences between BoNT-A and RES regarding the AP-LOS and ML-LOS were observed in favor of BoNT-A (p < 0.05). CONCLUSIONS: Integration of RES and BoNT-A has the capability to restore postural stability and ankle kinematics in diplegic children.

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