跳至主要内容
临床试验/CTRI/2025/07/091972
CTRI/2025/07/091972尚未招募2 期

Effect of CoDuSe and square stepping exercise on cognition, balance and risk of fall in patients with Parkinson’s disease

Pt. B. D. Sharma PGIMS, Rohtak, Haryana, India, 1240011 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年7月31日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Berg Balance Scale

研究概览

简要总结

Background: Parkinson’s disease (PD) is a progressive neurodegenerative disorder marked by motor and non-motor impairments that significantly affect quality of life. Falls and cognitive decline are common and debilitating complications in PD. While individual exercise programs have shown benefits, there is limited research on integrated interventions targeting multiple domains.

Objective: To evaluate the effects of a combined CoDuSe (Core, Dual-task, Sensory) and Square Stepping Exercise (SSE) program on cognition, balance, and risk of fall in patients with PD.

Methods: A true experimental, pretest-posttest design was used with 40 patients diagnosed with idiopathic PD (Hoehn and Yahr stage 2–3). Participants were randomly allocated into two groups:

  • Group A (n=20): SSE only (control group)
  • Group B (n=20): CoDuSe + SSE (experimental group)

Intervention was conducted over 4 weeks, 3 sessions per week. Outcome measures included Berg Balance Scale (BBS), Mini-Cog Scale, and Fall Efficacy Scale-International (FES-I). Data analysis was performed using descriptive statistics and t-tests.

Results: Results are to be analyzed post-intervention. It is hypothesized that the combined CoDuSe and SSE group will show statistically significant improvements in balance, cognition, and reduced fall risk compared to SSE alone.

Conclusion: This study aims to provide evidence supporting a comprehensive, dual-modality exercise intervention to improve functional outcomes in PD patients. If effective, this integrated approach could be adopted in rehabilitation protocols to reduce fall risk and enhance cognitive and motor performance in PD.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
50.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • All patients diagnosed with idiopathic Parkinson’s disease.
  • Both male and female will be included.
  • On modified Hoehn and Yahr scale 2 and 2.5 and 3
  • Participants voluntarily agree to participate in the study.

排除标准

  • Participants with ay other neurological disease.
  • Patients having depression or any significant behavioral disorder.
  • Patients with unstable medical or surgical conditions.
  • Patients not willing to participate.

结局指标

主要结局

Berg Balance Scale

时间窗: Baseline (day 0), post-intervention (week 4)

次要结局

  • Fall Efficacy Scale International(Baseline (day 0), post-intervention (week 4))
  • Mini Cog Scale(Baseline (day 0), post-intervention (week 4))

研究者

发起方
Pt. B. D. Sharma PGIMS, Rohtak, Haryana, India, 124001
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Akanksha Mittal

College of Physiotherapy , PGIMS, Pt. B. D. Sharma University of Health Sciences

研究点 (1)

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