跳至主要内容
临床试验/NCT06490809
NCT06490809招募中不适用

Examining the Clinical Significance of the Change in Manual Dexterity of Parkinson's Patients Receiving Conventional Physiotherapy

Emre Şenocak2 个研究点 分布在 2 个国家目标入组 44 人开始时间: 2024年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
44
试验地点
2
主要终点
Global Rating of Patient-Perceived Changes (GRP-PC)

研究概览

简要总结

The aim of this study is to examine the level of clinical change in gross manual skills of Parkinson's patients who receive conventional physiotherapy. For this purpose, the Box-Block Test will be used, and the amount of change that must occur in the patient's hand functions will be determined for the test to be considered clinically meaningful.

Patients will continue their routine physical therapy sessions and the researchers will not interfere with this program. The treatment program will be created by the clinical specialist physician and physiotherapist.

Upper extremity rehabilitation programs for Parkinson's patients generally consist of methods such as stretching, strengthening, reaching, coordination and recreational activities. Patients will receive physiotherapy for 30 sessions.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

盲法说明

An independent Researcher will perform a statistical analysis.

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Being Hoehn & Yahr Stage between 1-3,
  • Individuals in the "On" phase,
  • Those who were not exposed to any physiotherapy intervention during the initial assessment

排除标准

  • Mini-mental status assessment < 24 points;
  • Presence of severe dyskinesia,
  • Those who experience fluctuations in the on-off phase,
  • Those who have undergone stereotaxic brain surgery for Parkinson's,
  • Individuals with changes in dopamine dose within three months,
  • Presence of unstable cardiac and respiratory disease
  • Those with an orthopedic problem or a history of surgery affecting upper extremity performance.

结局指标

主要结局

Global Rating of Patient-Perceived Changes (GRP-PC)

时间窗: 6 weeks (5 session days for 6 weeks)

GRP-PC will used to assess patient-perceived hand dexterity changes after the routine intervention. The patient will first asked, "Has your hand dexterity changed compared to when you did not receive interventions?". If the answer is no, the person will given a score of 0 (i.e. no change). In the case of positive response, the patient will asked, "How much better or worse is your hand dexterity" and the patient response will scored on the following 14-point Likert scale: +7 (very much better), +6 (much better), +5 (better), +4 (relatively better), +3 (somewhat better), +2 (a little better), +1 (very little better), -1 (very little worse), -2 (a little worse), -3 (somewhat worse), -4 (relatively worse), -5 (worse), -6 (much worse), and -7 (very much worse). This form will only be used to classify patients' satisfaction with treatment at the end of the study.

Box and Block Test

时间窗: 6 weeks (5 session days for 6 weeks)

This test assesses gross manual dexterity. The number of wooden blocks moved during 60 seconds gives the total score. A high score indicates good dexterity.

次要结局

  • Demographic Data Form(Baseline of the study)

研究者

发起方
Emre Şenocak
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Emre Şenocak

Research Assisstant

Karadeniz Technical University

研究点 (2)

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