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临床试验/CTRI/2024/09/073648
CTRI/2024/09/073648尚未招募2 期

The efficacy of Neuro-Cognitive Therapeutic Interventions for improving upper extremity functions in patients with Acquired Brain Injury – A double-blinded, parallel-arm, Randomized Controlled Trial.

Christian Medical College1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年9月22日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
40
试验地点
1
主要终点
1. To develop a Neuro-Cognitive Therapeutic Intervention protocol for patients.

研究概览

简要总结

Motor and sensory impairments, particularly in upper limb function, are prevalent following Acquired Brain Injury (ABI) and often a primary focus of rehabilitation goals. Rehabilitation aims to promote motor recovery through various intervention techniques. A variety of techniques is used to address upper limb impairments post-ABI. Task-oriented training improves functional use of the affected limb, while splinting and casting support positioning, prevent contractures, and facilitate functional use. Constraint- induced movement therapy and mirror therapy leverage neuroplasticity principles to overcome learned non-use and promote cortical reorganization. Virtual reality provides engaging environments for practicing upper limb movements. Compensatory strategies and use of adaptive equipment are taught when functional recovery is limited. All of these methods have their own merits and demerits. One of the emerging interventions in the Upper limb Rehabilitation is Cognitive Exercise therapy (CET).

CET focuses on retraining the perceptual and cognitive processes to facilitate upper extremity sensori-motor functions. It is based on the assumption that by training cognitive processes involved in perception, attention, memory, and learning, this will in turn support neuroplasticity changes and the recovery of upper extremity functions. However, research on finding the efficacy of CET on ABI patients is limited. This study aims to evaluate the efficacy of NCTI along with usual occupational therapy to improve upper extremity functions. The patients with ABI who are getting admitted in A2, Q3 wards and rehabilitation center, and who fulfill the inclusion criteria will be randomly divided into two groups as experimental group and control group. The patients in the control group will receive usual occupational therapy intervention for 2 hours per day. The patients in the experimental group will receive usual occupational therapy intervention for 1 hour and Neuro-Cognitive Therapeutic Interventions for 1 hour per day. Hence both groups will receive 2 hours of therapy per day, 5 days a week for 4 weeks. Both the groups will receive medical and other therapeutic interventions such as Physiotherapy, speech therapy etc as their regular interventions.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
16.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • inclusion criteria includes
  • Medically stable patients after final approval from the treating neurologist
  • Patients with Acquired Brain Injury presenting with hemiplegia and / or hemiparesis.
  • Less than 2 years since the onset of the stoke
  • Ability to follow 3 step commands
  • Sitting endurance for 30 mins.
  • Brunnstrom stage 3 and above
  • MMT minimum of grade 2.

排除标准

  • the exclusion criteria includes
  • Secondary complications like T/C/D, heterotopic ossification.
  • Orthopedic conditions affecting upper limb functions.
  • Somatognosia and neglect
  • Modified Ashworth Scale 2 and above
  • Shoulder pain more than grade 6 on Numeric Pain rating scale (NRS)
  • Shoulder subluxation more than grade 2 in finger breadth grading scale.

结局指标

主要结局

1. To develop a Neuro-Cognitive Therapeutic Intervention protocol for patients.

时间窗: 1. Baseline | 2. After 4 weeks

with Acquired Brain Injury.

时间窗: 1. Baseline | 2. After 4 weeks

2. To find the efficacy of Neuro-Cognitive Therapeutic Interventions in improving

时间窗: 1. Baseline | 2. After 4 weeks

upper extremity functions.

时间窗: 1. Baseline | 2. After 4 weeks

次要结局

  • 1. To find the efficacy of Neuro Cognitive Therapeutic Interventions in improving(ADL functions & cognition.)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

V Ramya

Christian Medical College

研究点 (1)

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