Effect of Adding Computerized Executive Training on Balance, Motor Symptoms and Gait in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Adding Computer-based Executive Training to Conventional Rehabilitation Can Affect Postural Stability , Motor Symptoms and Gait in Parkinson's Disease Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06104072
• Other study ID #: P.T.REC/012/004746
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: May 2024
• Source: Cairo University
• Contact: Engy B Saleh, PhD
• Phone: 00201099445112
• Email: engybm.saleh[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

BACKGROUND: Postural instability is one of the cardinal signs 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, Parkinson's motor symptoms, and gait performance in Parkinson's disease patients.

Description:

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 68 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 November 2023 to April 2024.

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, in addition to sham computerized cognitive training. Patients in (GB) will be treated with computer-based cognitive training using REHACOM in addition to the same physiotherapy program as GA. Rehacom software will be used for the real computerized cognitive sessions, Cognitive training targets four main cognitive domains; attention/concentration, figural memory, auditory response control, and visual response control. . The treatment protocol will include 24 sessions, three sessions per week, for two successive months.

Primary Outcomes:

1. Postural stability:

• Biodex balance system was used to assess dynamic balance indices ( Overall stability index, mediolateral stability & anteroposterior stability)

2. Spatio-temporal gait parameters:

• Digital video camera and kinovea (video motion analysis software) was used to assess spatiotemporal gait parameters (Stride length, velocity & Cadence).

Secondary Outcomes:

1. Overall cognitive functions:

• Parkinson's Disease - Cognitive Rating Scale (PD-CRS).

2. Severity of Parkinson's motor symptoms:

• Using Unified Parkinson's disease rating scale (UPDRS)- motor subscale

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: May 30, 2024
• Est. primary completion date: May 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 58 Years to 68 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• REHACOM Software
It is a computer-based cognitive rehabilitation test that includes 32 cognition training tasks for attention/concentration, reaction behavior, memory , logical reasoning & executive functioning with graded difficulty . It is composed of regular PC , 1G RAM , DVD drive, 100 GB hard drive with windows XP SP3, 128 MB RAM direct 3D graphic card , Screen at least 19" , regular PC keyboard or Rehacom panel & printer .The Rehacom software version is (patientenpult (1990-1997) EN/ISO-13485-certified). For each Cognitive training domain there is one hundred levels of difficulty. Each patient is evaluated from level one(1) ang gradually increase the difficulty till we reach the level that will be used in the treatment sessions as the patient's performance improve we can proceed to the next level. The period of the session was chosen to be maximum (60 minutes) for each patient with five minutes rest in between each level.

Other:
• Designed Physical Therapy Program
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.

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy, Cairo University	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Engy Badreldin Saleh Moustafa, PhD

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Stability Index	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).	Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)
Primary	Anterior / posterior (A/P) index	o Anterior / posterior (A/P) index represents the patient's ability to control balance in front to back direction.	Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)
Primary	Medial/ lateral (M/L) index	o Medial/ lateral (M/L) index: represents the patient's ability to maintain balance from side to side.	Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)
Primary	Velocity of Gait	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.	Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)
Primary	Cadence of Gait	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.	Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)
Primary	Stride Length	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).	Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)
Secondary	Overall cognitive performance	Parkinson's Disease - Cognitive Rating Scale (PD-CRS) was conducted for each patient from a comfortable sitting position on a chair with back support and suitable seat height compared to a table in front of the patient.; The following cognitive domains were assessed: - Immediate free recall verbal memory (12 points), Confrontation naming (20 points), - Sustained attention (ten points), Working memory (ten points), - Visuo-constructional skills (Unprompted drawing of a clock) (ten points), Visuo-perceptual skills (Copy drawing of a clock) (ten points), - Delayed free recall verbal memory (12 points),Alternating verbal fluency (20 points) and - Action verbal fluency (30 points).; The overall total score for the (PD-CRS) is 134, the lower the score the more the cognitive impairment. The inclusion criteria for PD patients with cognitive decline indicated that a score 65-84 was the optimal cutoff point on the total score for the PD-CRS indicating mild cognitive impairment.	Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)
Secondary	Severity of Parkinson's motor symptoms	• Unified Parkinson's Disease Rating Scale (UPDRS- part III motor subscale) was used to assess 14 domains of motor symptoms in PD patients such as tremors, rigidity, freezing gait, toe and finger tapping, speech, stooped posture, postural stability and gait. Each domain is rated on 5 ordinal rating scale (from 0 to 4), maximum scoring for this subscale is 56, the higher the score the more the severity of the disease.	Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)