跳至主要内容
临床试验/CTRI/2024/03/064402
CTRI/2024/03/064402尚未招募不适用

The Impact Of Reverse Walking Training On Functional Balance And Gait Velocity In Individuals With A Diagnosis Of Stroke

SPES Super Speciality Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Functional Balance Improvement:

研究概览

简要总结

  1. Recruitment and Screening: Participants meeting the inclusion criteria would be recruited from stroke rehabilitation centres or outpatient clinics. They would undergo a screening process to confirm their eligibility for the study. Informed consent would be obtained from all participants. 2. Baseline Assessment: Before the intervention, baseline assessments of functional balance and gait velocity would be conducted using standardized tools such as the Berg Balance Scale, Timed Up and Go test, 10-Meter Walk Test, and/or other relevant measures. Additional demographic and clinical data may also be collected. 3. Randomization and Group Allocation: Participants would be randomly assigned to either the experimental group or the control group using an appropriate randomization method. Group allocation would be concealed from both the researchers and the participants, whenever possible. 4. Experimental Group - Reverse Walking Training: Participants in the experimental group would undergo a structured reverse walking training program. The training program would consist of exercises and tasks specifically designed to challenge balance, coordination, and gait patterns in a backward walking direction. The duration, frequency, and intensity of the training sessions would be predetermined and standardized for all participants in this group. 5. Control Group - Standard Care or Placebo Intervention: Participants in the control group would receive standard care or a placebo intervention that does not specifically target balance or gait. This could involve usual rehabilitation therapies or activities that do not directly impact functional balance and gait. 6. Monitoring and Progress Evaluation: Throughout the study period, participants’ progress and adherence to the intervention will be monitored. Any adverse events or side effects would be documented and addressed accordingly. 7. Post-intervention Assessment: After the intervention period, a post-intervention assessment of functional balance and gait velocity will be conducted using the same standardized assessment tools as in the baseline assessment. This allows for a comparison of outcomes between the experimental and control groups. 8. Data Analysis: The collected data would be analysed using appropriate statistical methods to assess the impact of reverse walking training on functional balance and gait velocity. Statistical tests such as t-tests, ANOVA, or non-parametric equivalents would be used to determine any significant differences between the experimental and control groups. 9. Results and Conclusion: The findings will be interpreted, and conclusions will be drawn regarding the impact of reverse walking training on functional balance and gait velocity in individuals with a diagnosis of stroke. The study’s limitations and implications for future research or clinical practice will also be discussed

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Adults aged 18 years or older.
  • Individuals diagnosed with a stroke, either ischemic or haemorrhagic.
  • The stroke event occurred at least 6 months before the study.
  • Participants with mild to moderate impairments in balance and gait, as determined by standardized assessment tools (e.g., Berg Balance Scale, Timed Up and Go test).
  • Able to walk independently or with minimal assistance (e.g., assistive devices such as canes or walkers).
  • Medically stable and cleared for participation in physical activities by a healthcare professional.
  • Willingness to participate in a structured reverse walking training program for the duration of the study.
  • Ability to follow instructions and provide informed consent for participation.

排除标准

  • Severe cognitive impairments or inability to understand and follow instructions necessary for the reverse walking training program.
  • Severe physical disabilities or comorbidities that prevent participation in physical activities or the reverse walking training program.
  • Uncontrolled medical conditions that may pose a risk during the training program (e.g., uncontrolled hypertension, cardiac conditions).
  • Recent history of lower extremity surgery or injury that may affect balance or gait performance.
  • History of other neurological conditions or impairments that may significantly influence balance or gait abilities, independent of the stroke diagnosis.
  • Presence of unhealed wounds or skin ulcers that may be aggravated or worsened during the training program.
  • Pregnancy, as the training program may pose potential risks to the participant and the unborn child.
  • Inability or unwillingness to provide informed consent for participation.

结局指标

主要结局

Functional Balance Improvement:

时间窗: baseline, 4 weeks & 8 weeks

Measure: Berg Balance Scale (BBS)

时间窗: baseline, 4 weeks & 8 weeks

Criteria: Changes in BBS scores from baseline to post-intervention.

时间窗: baseline, 4 weeks & 8 weeks

次要结局

  • Long-Term Effects:(Comparison with Conventional Rehabilitation:Implications for Rehabilitation Protocols:)

研究者

发起方
SPES Super Speciality Hospital
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

DR MEENA GUPT

AMITY UNIVERSITY

研究点 (1)

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