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临床试验/ACTRN12616001468415
ACTRN12616001468415已完成未知

The efficacy of early rehabilitation after traumatic brain injury (TBI)

Professor Jennie Ponsford0 个研究点目标入组 104 人开始时间: 2016年10月21日最近更新:

试验速览

阶段
未知
状态
已完成
发起方
入组人数
104

研究概览

简要总结

This study aimed to evaluate the efficacy of commencing activities of daily living skills retraining during posttraumatic amnesia (PTA) (Treatment condition) following traumatic brain injury, compared with withholding such training until following PTA emergence (Treatment as Usual). The impact of delivering the systematic manualised activities of daily living intervention, provided by trained Occupational Therapists, on functional independence was the primary outcome measure, with length of stay, PTA duration, community integration, and agitated behaviour during PTA also analysed. Furthermore, goal attainment scaling outcomes within the Treatment group were explored and qualitative interviews completed with treating clinicians. Participants allocated to Treatment received individual ADL skills retraining during PTA provided by qualified occupational therapists. The treatment group showed greater gains in functional independence during their hospital stay than the Treatment as Usual Group. Participants allocated to the treatment group showed significantly greater gains on the Functional Independence Measure between baseline and PTA emergence. Gains were maintained at discharge from inpatient rehabilitation. Amount of therapy received each day for participants within the Treatment group was not significantly associated with their daily agitation scores. Goal Attainment Scaling scores improved significantly from baseline to PTA emergence.

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
16 Years 至 o limit(—)
性别
All

入选标准

  • * Participants will have a severe TBI and have been admitted to the Brain Injury Unit at Epworth Hospital in Melbourne while in the PTA phase of recovery. Participants must be in the PTA phase of recovery as the primary focus of the project is to examine the efficacy of ADL retraining during PTA.
  • * Participants will be able to consistently follow single stage commands in order to demonstrate the ability to engage in re-training of activities of daily living.
  • * Participants will be physically able to participate in (at least one of) the movement/s required for particular ADL retraining.
  • * For participants to remain in the study, they will need to continue to be in PTA for at least one week, following commencement of participation. Learning and functional skill development is often slowed in individuals with severe TBI and therefore this minimum time frame has been applied. If any shorter time frame were to apply it would be unrealistic to capture treatment outcomes versus standard practice. Those who emerge from PTA within one week of commencement of the training will be excluded from the study.
  • * Participants will be medically stable in order to participate, as reported by their treating Physician.
  • * Participants will be required to have been independent with personal care activities pre-morbidly.

排除标准

  • * Admitted to hospital out of PTA
  • * In PTA for less than one week
  • * Cannot follow single-stage commands
  • * Cannot participate in ADL retraining due to physical limitations
  • * Are not medically stable
  • * Were not independent with personal care activities pre-injury

研究者

发起方
Professor Jennie Ponsford

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