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Walking ability of stroke patients: efficacy of tibial nerve blocking and a polypropylene ankle-foot orthosis |
Beckerman H, Becher J, Lankhorst GJ, Verbeek AL |
Archives of Physical Medicine and Rehabilitation 1996 Nov;77(11):1144-1151 |
clinical trial |
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: No; 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* |
OBJECTIVE: To investigate the efficacy of tibial nerve blocking by percutaneous radiofrequency thermocoagulation and an ankle-foot orthosis on the walking ability of stroke patients with a spastic equinus or equinovarus foot. DESIGN: A placebo-controlled randomized clinical trial with a 2x2 factorial design and with a 3-month follow-up. SETTING: Outpatient clinic of a department of rehabilitation medicine. SUBJECTS: Sixty stroke patients (17 women, 43 men) with a median age of 58 years and a median period of 34 months poststroke were allocated to one of four treatment groups. MAIN OUTCOME MEASURES: Changes in walking ability (measured with the Sickness Impact Profile category "ambulation"; possible score range 0% to 100%) and walking speed after 3 months. RESULTS: With respect to walking ability, the efficacy of thermocoagulation as compared with placebo thermocoagulation was 0.56% (95% confidence interval (CI) -3.01% to 4.13%), whereas the efficacy of the ankle-foot orthosis as compared with the placebo ankle-foot orthosis was 2.72% (95% CI -0.94% to 6.38%). To study the potential synergistic effect of both treatments, a multivariate model was used; interaction between both treatments was small, 0.83% (95% CI -6.73% to 8.40%). Analysis restricted to the compliers (n = 30) showed an increased efficacy of thermocoagulation and a decreased efficacy of the ankle-foot orthosis. The changes in comfortable and maximal safe walking speed were less than 0.10m/sec and were neither clinically nor statistically significant (the median baseline values for the total group were 0.42m/sec and 0.56m/sec, respectively). CONCLUSION: No support was found for the beneficial effects of either thermocoagulation of the tibial nerve or a polypropylene ankle-foot orthosis in 5 degrees of dorsiflexion on the walking ability of stroke patients.
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