Adding Computer-based Cognitive Training to Conventional Rehabilitation Can Affect Postural Stability , Locomotion and Cognition in Parkinson's Disease Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Overall Stability Index
研究概览
简要总结
BACKGROUND: Postural instability and gait abnormalities are cardinal features in Parkinson's disease (PD). It represents one of the most disabling symptoms in the advanced stages of the disease.
The purpose of this study was to evaluate the immediate and long-term effects of adding computer-based cognitive training to physical therapy interventions on postural stability, locomotion, and cognitive performance in Parkinson's disease patients.
详细描述
Study design: A randomized control clinical trial among sixty-eight Egyptian Parkinson's Disease patients of both sexes participated in the study; their ages ranged from 55 to 70 years. They were selected from the Neurology Clinics and from the Movement Disorder Clinic, Neurology Department, Faculty of Medicine, Cairo University, in the period from May 2024 to March 2025.
The patients will be divided into two equal groups: the control group (GA) and the study group (GB). Patients in GA will be treated by a designed physiotherapy program consisting of aerobic exercise on a treadmill, stretching exercises, proprioceptive neuromuscular facilitation (PNF) techniques, graduated active exercises, gait training, reciprocal, and weight-shifting exercises for 60 minutes. Patients in (GB) will be treated with computer-based cognitive training using REHACOM (30 minutes) in addition to the same physiotherapy program as GA (30 minutes). Rehacom software will be used for cognitive training targeting four main cognitive domains; attention/concentration, figural memory, auditory response control, and visual response control. . The treatment session for all patients in both groups will be 60minutes/session. The whole treatment protocol will include 24 sessions, three sessions per week, for two successive months.
Primary Outcomes:
- Postural stability:
- Biodex balance system was used to assess dynamic balance indices ( Overall stability index, mediolateral stability & anteroposterior stability) 2. Spatio-temporal gait parameters:
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
- Double (Participant, Outcomes Assessor)
盲法说明
Patients participated will be masked about the type of intervention, where (GA) patients will receive PT program for 60 minutes, while patients in (GB) will receive computer -based REHACOM cognitive training (30 minutes) in addition to the same PT program as (GA)(30 minutes).
入排标准
- 年龄范围
- 58 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Egyptian Parkinson's Disease patients of both sex , all patients fulfilled the U.K Parkinson's Disease Brain Bank Criteria for diagnosis of idiopathic PD.
- •The patients' age ranged from 58 to 68 years.
- •The duration of illness ranged from two to five years.
- •The severity of the disease ranged from mild to moderate disability according to UPDRS motor scores (part III) and Modified Hoehn and Yahr staging (stage 2.5&3) .
- •Cognitive function ranged from 65 to 81 according to Parkinson's Disease-Cognitive Rating Scale (PD-CRS) that indicates mild cognitive impairment.
- •The patients with mild balance and gait impairments
- •Medically and psychologically stable patients and of adequate cardiac function to adhere to the protocol.
排除标准
- •Patients with secondary parkinsonism (Drug-induced, post traumatic, or post infectious) or atypical parkinsonism.
- •Patients with major language disturbance, severe physical, auditory or visual impairment affecting their ability to complete testing.
- •Patients with magnetic devices or any other implanted device (e.g., metallic implants such as pacemakers, surgical aneurysm clips…etc).
- •Patients with a history of seizure, head injury or brain surgery.
- •Complicating or unstable cardiovascular disease (unstable angina, recent myocardial infarction within the last three months, congestive heart failure, significant heart valve dysfunction, or unstable hypertension) or pulmonary disorders.
- •Patients with musculoskeletal disorders such as severe arthritis, knee surgery, total hip joint replacement, lower limb fractures or contractures of fixed deformity.
- •Patients with evidence from the history, physical examination, or special investigations for any concomitant medical or metabolic illness known to affect cognition e.g. cerebrovascular stroke, thyroid or parathyroid disease, hepatic or renal failure.
- •Patients receiving certain drugs known to improve cognition (e.g. rivastigmine, memantine…..etc).
- •Patients with current or prior history of major psychiatric disorder and/or current use of anxiolytic, neuroleptic, sedative medication or sleeping aids.
- •Uncooperative patients.
- •Illiterate patients.
研究组 & 干预措施
Control group (GA)
Patients in control group (GA) will be treated by a designed physiotherapy program consisted of aerobic exercise on treadmill, stretching exercise, Proprioceptive neuromuscular facilitation (PNF) techniques, Graduated active exercises, gait training, Reciprocal and weight shifting exercises for 60 minutes/session, 3 days/week for 8 consecutive weeks
干预措施: A Designed Physical Therapy Program (Other)
Study group (GB)
Patients in (GB) will be treated by computer-based cognitive training for 30 minutes followed by the same physiotherapy program as GA for another 30 minutes. so the whole duration of the treatment session for (GB) is 60 minutes ( half of the session the computerized cognitive training and the other half is for the designed physical therapy program). the whole treatment intervention will be 3 days /week for 8 consecutive weeks.
干预措施: REHACOM Software (Device)
Study group (GB)
Patients in (GB) will be treated by computer-based cognitive training for 30 minutes followed by the same physiotherapy program as GA for another 30 minutes. so the whole duration of the treatment session for (GB) is 60 minutes ( half of the session the computerized cognitive training and the other half is for the designed physical therapy program). the whole treatment intervention will be 3 days /week for 8 consecutive weeks.
干预措施: A Designed Physical Therapy Program (Other)
结局指标
主要结局
Overall Stability Index
时间窗: Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)
o Overall balance index: represents the patient's ability to control balance in all directions. High values indicate balance disturbance (increase rate of body swaying during the test).
Stride Length
时间窗: Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)
Using 2D motion analysis in Kinovea program, stride length was the distance from the first initial contact of one foot (1st frame) to the next initial contact of the ipsilateral foot (2nd frame).
Anterior / posterior (A/P) index
时间窗: Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)
o Anterior / posterior (A/P) index represents the patient's ability to control balance in front to back direction.
Cadence of Gait
时间窗: Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)
Using 2D motion analysis in Kinovea program for spatiotemporal gait analysis Cadence is the Number of steps/Minute * Number of steps: calculated by counting the steps the patient walked from the beginning to the end of the walkway (blue line). * Cadence was calculated by dividing the number of steps that the patient walked over the actual duration of walking.
Velocity of Gait
时间窗: Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)
Using 2D motion analysis in Kinovea program for spatiotemporal gait analysis o Velocity = Distance/Time * The total distance: represented by the actual length that the patient walked and this was presented by the blue line (three meters). * The total duration of walking (seconds): was calculated by using the ''stop watch'' tool in kinovea program. Velocity meter/seconds: was calculated by dividing the total distance that had been walked by the patient over the total duration.
Medial/ lateral (M/L) index
时间窗: Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)
o Medial/ lateral (M/L) index: represents the patient's ability to maintain balance from side to side.
次要结局
- Overall cognitive performance(Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up))
研究者
Engy Badreldin Saleh Moustafa, PhD
Dr.
Cairo University