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临床试验/CTRI/2024/09/074001
CTRI/2024/09/074001尚未招募2/3 期

Efficacy of dynamic neuromuscular stabilization technique versus pelvic proprioceptive neuromuscular facilitation technique on dynamic trunk balance of patients with chronic stroke

Manali Sonawane1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年10月4日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
1. Trunk Impairment Scale (TIS)

研究概览

简要总结

After evaluating the subjects based on the inclusion and exclusion criteria, those who qualify will be enrolled in the study. Participants will then fill out a consent form and be provided with a detailed explanation of the procedure.

Participants will be assigned to one of two groups: either the Pelvic Proprioceptive Neuromuscular Facilitation (PNF) Group (Group A) or the Dynamic Neuromuscular Stabilization (DNS) Group (Group B) using computer-generated purposive sampling. Each group will receive instructions on how to perform the exercises and how the testing will be conducted. Prior to the commencement of the protocol, the subjects will be assessed using various outcome measures, including the Trunk Impairment Scale (TIS), Stroke-Specific Quality of Life Scale (SS-QOL), Berg Balance Scale, and Tinetti Test.

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Group A– Experimental group-

Subjects in Group A will receive a protocol of Pelvic PNF for 30 minutes, 3 alternate days a week for a total duration of 4 weeks (12 sessions) following conventional therapy. Each technique will be given for 10 minutes. These procedures will be conducted to facilitate anterior elevation and posterior depression, as well as posterior elevation and anterior depression of the pelvis in a side-lying position on the affected side. Appropriate rest time will be provided to each patient in between the protocol according to the patients’ comfort. The elements of PNF, such as manual contact, stretch, resistance, and verbal cuing, will be incorporated into the treatment scheme.

Group B - Experimental Group

Subjects in Group B will receive a combined therapy of DNS and conventional physiotherapy, which will include trunk, pelvis, and lower limb training. DNS will include several developmental pattern exercises where the therapist will position their thumbs on the chest area and encourage regular breathing patterns while supporting the descent of the diaphragm to engage its stabilizing function. The DNS treatment will involve a protocol consisting of 12 developmental pattern exercises that engage reflex-mediated diaphragm facilitation. This will activate the core stabilizers by positioning the vertebral column, ribcage, pelvis, and scapula in alignment. For the first week, two to three developmental positions will be implemented to teach appropriate breathing patterns and stabilization. Over the following three weeks, three to four new patterns from the DNS techniques will be introduced. By the end of the fourth week, participants will be expected to successfully practice all the patterns illustrated in the DNS. This will include diaphragmatic breathing, the three-month supine position with hips, knees, and ankles at 90-degree flexion, the prone three-month position with upper arms at a 90-degree angle to the trunk, supported on elbows, and the side-lying 5th-month position where the patient will lie on the side with the lower shoulder supported, elbow flexed, wrist in a neutral position, and the lower limb supported in a semi-flexed position at the knee, aligning the heel and hip with the ischial tuberosity. Treatment will be provided for 30 minutes, 3 alternate days a week for a total duration of 4 weeks (12 sessions) following conventional therapy.

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Conventional exercises for both the groups will include the active range of motion (ROM) exercises, stretching of the tightened muscles, mat exercises for stability, functional training for ADL.

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
45.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Chronic stage of stroke.
  • Left or right hemiplegic stroke.
  • 45-65 years.
  • male and female participants.
  • Comprehend and able to follow commands.

排除标准

  • cognitive dysfunction.
  • Neurological abnormalities such as Dementia, Alzheimer’s disease.
  • Unstable medical condition.
  • Respiratory disorders and cardiac disorders.
  • Fixed deformities and contractures.
  • Enrolled in different clinical trials.
  • Unwilling or refused to participate.

结局指标

主要结局

1. Trunk Impairment Scale (TIS)

时间窗: T1 and T2 | T1- Pre intervention (baseline) | T2 Post intervention

2. Tinetti Test

时间窗: T1 and T2 | T1- Pre intervention (baseline) | T2 Post intervention

次要结局

  • Stroke-specific Quality of life scale (SS-QOL)(T1 and T2)

研究者

发起方
Manali Sonawane
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Ms Manali Sonawane

Lovely Professional University

研究点 (1)

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