The effect of a therapeutic regimen of Traditional Chinese Medicine rehabilitation for post-stroke cognitive impairment: study protocol for a randomized controlled trial.

Jia Huang; Zhengkun Lin; Qin Wang; Feiwen Liu; Jiao Liu; Yunhua Fang; Shanjia Chen; Xiaoxuan Zhou; Wenjun Hong; Jinsong Wu; Madrigal-Mora, Natalia; Guohua Zheng; Shanli Yang; Jing Tao; Lidian Chen; Huang, Jia; Lin, Zhengkun; Wang, Qin; Liu, Feiwen; Liu, Jiao

Background: Post-stroke cognitive impairment (PSCI) lessens quality of life, restricts the rehabilitation of stroke, and increases the social and economic burden stroke imposes on patients and their families. Therefore effective treatment is of paramount importance. However, the treatment of PSCI is very limited. The primary aim of this protocol is to propose a lower cost and more effective therapy, and to confirm the long-term effectiveness of a therapeutic regimen of Traditional Chinese Medicine (TCM) rehabilitation for PSCI. Methods/design: A prospective, multicenter, large sample, randomized controlled trial will be conducted. A total of 416 eligible patients will be recruited from seven inpatient and outpatient stroke rehabilitation units and randomly allocated into a therapeutic regimen of TCM rehabilitation group or cognitive training (CT) control group. The intervention period of both groups will last 12 weeks (30 minutes per day, five days per week). Primary and secondary outcomes will be measured at baseline, 12 weeks (at the end of the intervention), and 36 weeks (after the 24-week follow-up period). Discussion: This protocol presents an objective design of a multicenter, large sample, randomized controlled trial that aims to put forward a lower cost and more effective therapy, and confirm the long-term effectiveness of a therapeutic regimen of TCM rehabilitation for PSCI through subjective and objective assessments, as well as highlight its economic advantages. Trial Registration: This trial was registered with the Chinese Clinical Trial Registry (identifier: ChiCTR-TRC-14004872 ) on 23 June 2014.

CHINA; COGNITION disorders research; STROKE; COGNITIVE training; QUALITY of life; RANDOMIZED controlled trials; COGNITION disorders diagnosis; STROKE diagnosis; ACUPUNCTURE; COGNITION; COGNITION disorders; COGNITIVE therapy; COMPARATIVE studies; COST effectiveness; EXPERIMENTAL design; HEALTH surveys; LONGITUDINAL method; RESEARCH methodology; MEDICAL care costs; MEDICAL cooperation; RESEARCH protocols; QUESTIONNAIRES; RESEARCH; TIME; EVALUATION research; TREATMENT effectiveness; BLIND experiment; COGNITIVE rehabilitation; STROKE rehabilitation; PSYCHOLOGICAL factors; PSYCHOLOGY

Trials, 2015, Vol 16, Issue 1, p1

1745-6215

Academic Journal

10.1186/s13063-015-0795-x