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临床试验/NCT07263646
NCT07263646尚未招募不适用

The Effect of Balance-focused Exercise Programme in Enhancing the Solus-muscle Activation During Gait Initiation for People With Parkinson Disease

Ministry of Health, Kuwait2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年1月22日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
试验地点
2
主要终点
gait analysis

研究概览

简要总结

Gait initiation (GI) is a crucial component of walking that requires a balanced muscle activity and postural stability. GI could be challenging for people with neurological condition such as people with Parkinson (PWP), where GI is usually impaired. The purpose of this study is determining effectiveness of comprehensive, balanced-focused exercise programme in controlling the activation of Solus-muscle in people with Parkinson disease. We hypothesise that balance-focus exercise programe could improve Solus-muscle activation during GI.

study type: this is a parallel group prospective (10 weeks) randomised single-blinded controlled trial conduct in Kuwait.

Participant: People with Parkinson, who met the inclusion criteria.

详细描述

Parkinson's Disease (PD), a neurodegenerative disorder characterised by motor dysfunction . The basal ganglia play a significant role in regulating muscle excitation, and its dysfunction in PD leads to abnormal activation patterns in muscles such as the soleus, crucial for walking. This contributes to symptoms like bradykinesia, resulting in slower movement, shuffling gait, and difficulty initiating walking. Prolonged activation of the plantar flexor muscles, especially the soleus, disrupts the forward momentum needed for normal walking.

Gait initiation (GI) is a crucial component of walking that requires a balanced muscle activity and postural stability. The GI process requires a propulsive force to move the body across a distance (from a bipedal stance to repeating gait cycles) while maintaining postural stability. Thus, GI could be challenging for people with neurological condition such as people with Parkinson (PWP), where GI is usually impaired.

Any modification to the GI program could affect postural stability and the velocity of the movement and any impairment in muscle activation of the lower limb will interfere with the GI process, .

This underscores the significance of the altered muscle excitation pattern observed in PWP and its potential impact on motor control. This imbalance can contribute to the prolonged muscle activation times and differential speed changes observed in muscle activation patterns.

Bradykinesia is a slow movement during the execution of common physical activities, such as the activities of daily living (ADL). That could be because PWP tend to keep the plantar flexor muscles mainly (solus) contracted for longer time. This prolonged muscle activity interferes with the gravity-assisted forward rotation of the body resulting adverse affects on the timing of subsequent events during gait initiation.

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 (Outcomes Assessor)

盲法说明

the outcomes assessor will not be aware of the group allocation

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

  • participants diagnosed by their neurologist with Parkinson's disease (moderate to severe stage)
  • stable on anti-Parkinson's drugs
  • able to walk independently without a frame or walking stick.
  • Able to walk for more than 10 mins unaided
  • without cognitive disability (Able to follow simple instructions and communicate, orally),
  • have good vision (with or without corrective aids)

排除标准

  • are pregnant
  • cardiac problems exacerbated by exercise
  • currently complaining of joint or muscle problems that affect walking ability
  • known to have neurological conditions (other than Parkinson) that affect walking ability
  • uncorrected hearing or vision problems
  • history of severe motion sickness
  • history of vestibular or balance problems
  • an active skin condition that could be irritated by contact with sticky tape.

结局指标

主要结局

gait analysis

时间窗: baseline

• Three-dimensional motion analysis:Motion capture units will track the movement of reflective markers placed on the skin/clothing of participants.

electromyography EMG

时间窗: 6 weeks

Electric activity of the muscles using the wireless EMG measurement system. The system will track the activity of solus muscle (left and right).

weight

时间窗: baseline

weight of the person in KG

height

时间窗: baseline

the height of the person in CM

gait analysis

时间窗: 10 weeks

Three-dimensional motion analysis: Motion capture units will track the movement of reflective markers placed on the skin/clothing of participants.

Gait Analysis

时间窗: 6 weeks

Three-dimensional motion analysis: Motion capture units will track the movement of reflective markers placed on the skin/clothing of participants.

• electromyography (EMG)

时间窗: baseline

Electric activity of the muscles using the wireless EMG measurement system. The system will track the activity of solus muscle (left and right).

electromyography EMG

时间窗: 10 weeks

Electric activity of the muscles using the wireless EMG measurement system. The system will track the activity of solus muscle (left and right).

次要结局

  • Parkinson severity scale PDQ-39(6 weeks)
  • Parkinson severity scale (PDQ-39)(baseline)
  • Parkinson severity scale PDQ-39(10 weeks)
  • Timed Up and Go test (TUG)(baseline)
  • Timed Up and Go test TUG(6 weeks)
  • time up and go TUG(10 weeks)
  • PITTSBURGH rehabilitation participation scale(6 weeks)
  • patient satisfaction(6 weeks)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Esraa Aldayil

chief of physiotherapy

Ministry of Health, Kuwait

研究点 (2)

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