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临床试验/NCT03815409
NCT03815409已完成不适用

Rehabilitation of Parkinsonian Gait in Body Weight Support Combined With Treadmill: a Controlled Study

IRCCS National Neurological Institute "C. Mondino" Foundation0 个研究点目标入组 36 人开始时间: 2007年11月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
主要终点
speed of gait

研究概览

简要总结

Gait disorders represent disabling symptoms in Parkinson's Disease (PD). The effectiveness of rehabilitation treatment with Body Weight Support Treadmill Training (BWSTT) has been demonstrated in patients with stroke and spinal cord injuries, but limited data is available in PD. The aim of the study is to investigate the efficacy of BWSTT in the rehabilitation of gait in PD patients. Thirty-six PD inpatients were enrolled and performed rehabilitation treatment for 4 weeks, with daily sessions. Subjects were randomly divided into two groups: both groups underwent daily 40-minute sessions of traditional physiokinesitherapy followed by 20-minute sessions of overground gait training (Control group) or BWSTT (BWSTT group). The efficacy of BWSTT was evaluated with clinical scales and Computerized Gait Analysis (CGA). Patients were tested at baseline (T0) and at the end of the 4-week rehabilitation period (T1).

详细描述

Gait disorders in Parkinson Disease (PD) are due to dopaminergic nigrostriatal pathways degeneration and represent important components of the disability.

In PD, gait is characterized by a significant reduction of stride length. Inadequate flexion at the ankle and knee, reduction of heel strike, forward-flexed trunk, reduced arm swing with asymmetric stride times for lower limbs and significant stride-to-stride variability are frequently associated.

The efficacy of pharmacological treatment with Levodopa is frequently incomplete and adjuvant rehabilitation treatment is recommended. Body weight-supported treadmill training (BWSTT) represents a promising rehabilitative approach for gait impairment in PD. Effectiveness of BWSTT on gait, balance and motor function has been demonstrated in different neurological diseases, especially in stroke and spinal cord injury. In PD patients, BWSTT has been tested in small controlled studies that have suggested a clinically detectable beneficial effect. BWSTT seems also effective in improving balance in PD. In PD, many data in literature show how treadmill training, acting as a sensory cue, improves kinetic and kinematic parameters, studied with computerized gait analysis (CGA) more than physiotherapy alone.

The first report of BWSTT efficacy in gait rehabilitation of PD belongs to Miyai. Ten patients with PD were enrolled in a cross-over study and treated for 4 consecutive weeks with BWSTT (20% of unweighting for 12 minutes followed by another 12-min period of 10% of unweighting) or conventional physical therapy (CPT). The Authors showed that BWSTT was superior to CPT in improving gait disturbances and disability at the end of the rehabilitative period. More specifically BWSTT proved superior to CPT in improving UPDRS scores, gait speed and stride length. The same study group in 2002 evaluated the 6-month retention of BWSTT in PD. Twenty-four patients with PD were randomized to receive BWSTT (20% of unweighting for 10 minutes + 10% of unweighting for 10 minutes + 0% of unweighting for an additional 10-min period) or CPT 3 times/week for 4 consecutive weeks. All patients were clinically evaluated at baseline and them monthly for 6 months. In this series, gait speed significantly improved in BWSTT respect to CPT only at month 1, while the improvement in the stride length was more marked in BWSTT group with respect to CPT and persisted until month 4.

In 2008 Fisher speculated on the possible central mechanism responsible for clinical effects f BWSTT. Thirty subjects affected by PD were randomly assigned to three groups: high-intensity group (24 sessions of BWSTT), low-intensity group (24 sessions of CPT), zero-intensity group (8 weeks of education classes). Again, the high-intensity group improved the most at the end of treatment period, in particular in gait speed, step length, stride length and double support. Of note, that in this study a subgroup of patients was also tested with transcranial magnetic stimulation: in the BWSTT group Authors were able to record a lengthening of the cortical silent period, postulating that high-intensity training improved neuronal plasticity in PD, through BDNF and GABA modulation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • disease stage 2-3 Hoehn &Yahr in the "on" phase;
  • stable dosage of dopaminomimetic drugs for 3 months before study enrollment

排除标准

  • moderate to severe cognitive impairment (MMSE ≤ 21),
  • advanced PD (Hoehn and Yahr [H&Y] stage >3),
  • unpredictable motor fluctuations
  • moderate to severe orthopedic problems or other pathological conditions (e.g. severe postural abnormalities) that might affect gait training.

结局指标

主要结局

speed of gait

时间窗: after 4-week rehabilitative program

m/s - higher values represent better outcome

次要结局

  • stride duration(after 4-week rehabilitative program)
  • Functional Independence Measure (FIM)(after 4-week rehabilitative program)
  • Unified Parkinson's Disease Rating Scale III (UPDRS-III)(after 4-week rehabilitative program)
  • Cadence of step(after 4-week rehabilitative program)
  • stride length(after 4-week rehabilitative program)
  • stance(after 4-week rehabilitative program)
  • swing(after 4-week rehabilitative program)
  • number of strides in 10 meters(after 4-week rehabilitative program)

研究者

申办方类型
Other
责任方
Sponsor

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