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临床试验/NCT06539247
NCT06539247已完成不适用

Comparative Effects of Motor Relearning Approach Versus Proprioceptive Neuromuscular Facilitation Technique (PNF) on Pain, Foot Drop, Gait and Functional Mobility in Hemiplegic Patients

University of Lahore2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年1月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
试验地点
2
主要终点
Gait analysis

研究概览

简要总结

This single blinded randomized control study aimed to determine the comparative effectiveness of two rehabilitation approaches for improving pain, foot drop, gait, and functional mobility in patients with hemiplegia. The study recruited 68 patients diagnosed with hemiplegia who met specific inclusion criteria. Both groups received a treatment program lasting eight weeks, with assessments at baseline, week four, and week eight. The study measured various outcomes as gait analysis, foot drop grading, functional ability and pain assessment. This study aimed to contribute to evidence-based practice in stroke rehabilitation by comparing the effectiveness of motor relearning and PNF approaches for improving gait, pain, and functional mobility in hemiplegic patients. The findings may help guide therapists in selecting the most appropriate intervention for individual patients.

详细描述

Stroke is a leading cause of disability worldwide, with hemiplegia (muscle weakness or paralysis on one side of the body) being a common consequence. Rehabilitation plays a crucial role in improving gait, reducing pain and enhancing functional mobility for stroke patients. This study investigated the comparative effects of two rehabilitation approaches: Motor Relearning (MRP) and Proprioceptive Neuromuscular Facilitation (PNF).

Study Design: This was a randomized controlled trial with two parallel groups:

Group A: Motor Relearning Approach with Electrical Muscle Stimulation (EMS) Group B: Proprioceptive Neuromuscular Facilitation Technique (PNF) with Electrical Muscle Stimulation (EMS)

Randomization: Eligible participants were randomly assigned to either group using a lottery method to ensure balance between groups.

Blinding: The assessor evaluating outcomes were blinded to group allocation (single-blinded).

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

Single-blinded assessor was considered to minimize bias in outcome measurements. The assessor was unaware of the intervention group assignment for each participant.

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients having age between 45 to 65 years (Kagawa et al., 2013)
  • Hemiplegic, impaired functional mobility and dependent (Kanase, 2020)
  • Functional deficits in lower limb, with both the Sexes and any side (left or right) (Kanase, 2020)
  • Patients having hemiplegia within 6 months might be post-stroke, able to follow instructions (Kanase, 2020)
  • Diagnosed with hemiplegia having a stable neurological condition (e.g., stroke) (Anandan et al., 2020)
  • Minimum score of 12 on the Dynamic Gait Index (DGI) to ensure sufficient baseline gait function for meaningful comparison (Singha, 2017).
  • Grade 3 foot drop (Tibialis Anterior) on the Motor Assessment Scale in the affected leg to have room for improvement in both interventions (Singha, 2017).
  • Participants having moderate to severe pain of ≤ 4 (moderate) and ≥ 7 (severe) on numeric pain rating scale (NPRS) at rest , were included to minimize confounding effects of pain on gait and mobility (Beebe et al., 2021).
  • Mini-Mental State Examination (MMSE) score ≥ 24 (Page et al., 2007).

排除标准

  • Subjects having any medical condition that affects his/her performance (Kanase, 2020)
  • Completely recovered case of Hemiplegia in terms of walking abilities & upper limb activities (Kanase, 2020)
  • Subjects with Transient Ischemic Attack (Kanase, 2020)
  • Other neurological conditions such as severe cognitive impairments

结局指标

主要结局

Gait analysis

时间窗: 8 weeks (baseline, fourth week and then at the end of the 8 week)

The Dynamic Gait Index was a standardized tool used to assess gait function in individuals with lower extremity impairments. It evaluated 8 components of gait, with higher scores indicating better gait quality. A total score below 19 suggests a higher risk of falls, whereas scores above 22 are associated with safe ambulation

Foot Drop

时间窗: 8 weeks (baseline, fourth week and then at the end of the 8 week)

Manual Muscle Testing was a standardized test that assessed muscle strength on a 5-point scale (0 = no contraction to 5 = normal strength). This was used specifically for the affected leg's dorsiflexor muscles (Tibialis Anterior).

次要结局

  • Functional Ability(8 weeks (baseline, fourth week and then at the end of the 8 week))
  • Pain intensity(8 weeks (baseline, fourth week and then at the end of the 8 week))

研究者

发起方
University of Lahore
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hamna Sarfraz

Student

University of Lahore

研究点 (2)

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