ACTRN12622000183785进行中（未招募）未知
The efficacy of Transcranial direct current stimulation during rehabilitation following Anterior Cruciate Ligament (ACL) reconstruction on functional outcomes and return to play timelines. A double-blind randomised controlled trial (The TACL study)
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 26
研究概览
简要总结
暂无简介。
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
- 18 Years 至 60 Years（—）
- 性别
- All
入选标准
- •Participants who have suffered a non-contact, primary isolated ACL rupture during type one or two physical activity (using the IKDC classification system) without concurrent knee injury severe enough to require surgical intervention if the ACL was intact (e.g. concurrent PCL rupture or bucket handle meniscal tear would be excluded) will be eligible to participate within this study. Participants will have an ACLR using a hamstring graft. ACLR will occur within six weeks of ACL injury. Specifically:
- •Over 18 years of age
- •Acute non-contact, primary ACL rupture diagnosed clinically by an orthopaedic surgeon, confirmed with magnetic resonance imaging pre-surgery and confirmation of ACL rupture during surgery.
- •Able to proceed to ACLR within 4 weeks of baseline neurophysiological testing
- •Able to attend scheduled follow-up sessions
- •Able to give consent
排除标准
- •Concurrent knee injuries severe enough to require surgery (e.g. concurrent PCL rupture or bucket handle meniscal tear)
- •Previous lower limb surgery
- •Concurrent musculoskeletal injury to the lower limb
- •Conditions that may impact the safety of tDCS:18
- •Previous tDCS leading to adverse effects
- •Skin lesions or sensitive scalp
- •Neurological conditions/illness, including epilepsy/convulsion/seizure
- •Previous or current implants in their body that may be triggered or heated by an electrical current (e.g. pacemaker, intracranial shunts, artificial cochlea, etc)
- •Any mental implanted in their head (e.g. surgical clips, staples, shrapnel)
- •Frequent or intense headaches
- •Previous brain trauma or neurosurgical intervention
- •Serious medical complications (e.g. advanced pulmonary, cardiac, liver or kidney disease)
- •Pharmacological treatment for depression
- •Neuropsychotropic drugs (e.g. antiepileptics, neuroleptics, benzodiazepines, antidepressants) or drugs with an effect on neuroplasticity (dopamine, fluoxetine or D-amphetamine, sodium or calcium channel blockers, NMDA receptor antagonists)
- •History of significant alcohol or substance abuse, as identified through screening questionnaire
- •Conditions that may impact the safety of transcranial magnetic stimulation (TMS) use:19
- •History of epilepsy (treated or untreated)
- •Vascular, traumatic, tumoural, infectious, or metabolic lesion of the brain, even without history of seizure, and without anticonvulsant medication
- •Administration of drugs that potentially lower seizure threshold, without concomitant administration of anticonvulsant drugs which potentially protect against seizure occurrence
- •Sleep deprivation* the night before, alcoholism , as identified through screening questionnaire
- •Implanted brain electrodes (cortical or deep-brain electrodes)
- •Severe or recent heart disease
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