Photobiomodulation in Parkinson´s Disease: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- The motor portion of the MDS-UPDRS.
研究概览
简要总结
This study aimed to assess the effects of transcranial photobiomodulation in patients with Parkinson's disease (PD).
详细描述
Thirty-five patients with idiopathic PD were randomly assigned to a photobiomodulation (n=17, [mean±SD] 72±7 years) or sham group (n=18, 70±8 years) during 9 weeks (2 sessions/week). The primary endpoint was the motor portion of the Movement Disorders Society-United PD Rating Scale. Secondary endpoints were the Scales for Outcomes in PD, static posturography, walking ability (ten-meter walk test [TMWT]) and functional mobility (timed up and go [TUG] test).
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
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having been diagnosed with idiopathic PD.
- •Stage 1-2 on the Hoehn and Yahr Scale.
- •Having no neurological condition other than PD.
- •Being able to stand for 2 minutes and walk 10 meters without assistance.
- •Having no severe dyskinesias or "ON-OFF" phases.
排除标准
- •Do not follow inclusion criteria.
研究组 & 干预措施
Photobiomodulation group
17 Parkinson´s disease patients were randomly assigned to the photobiomodulation group (experimental group).
Intervention: Photobiomodulation was administered using red light-emitting diodes (LEDs) with a 670-nm wavelength in six 1-minute blocks alternating the LEDs between the right and left temples, with a 30-second rest between blocks.
干预措施: Transcranial photobiomodulation (Other)
Sham group
18 Parkinson´s disease patients were randomly assigned to the sham group.
Intervention: Procedures for the sham group were identical as the photobiomodulation one, except that patients received photobiomodulation during only 5 seconds followed by 55 seconds with no treatment (equalling 1/12th of the energy used for the intervention group).
干预措施: Transcranial photobiomodulation (Other)
结局指标
主要结局
The motor portion of the MDS-UPDRS.
时间窗: 9 weeks
The motor portion (part III) Movement Disorders Society-Unified PD Rating Scale. It assesses the motor signs of Parkinson´s disease (minimum and maximum score is 0 and 76 points respectively -the higher score, the higher movement disorder and vice versa-).
次要结局
- Motor function(9 weeks)
- Static posturography(9 weeks)
- Walking speed(9 weeks)
- TUG(9 weeks)
研究者
Luis Santos
Principal Investigator
University of Oviedo