Effect of Adding Computerized Cognitive Training on Balance, Locomotion and Cognition in Parkinson's Disease

NCT ID: NCT06104072

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-23
• Study Completion Date: 2025-04-20

Brief Summary

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.

Detailed 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 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:

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 Outcome:

a. Overall cognitive functions:

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

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: PLACEBO_COMPARATOR

A Designed Physical Therapy Program

Intervention Type: OTHER

A designed physiotherapy program consisted of aerobic exercise on treadmill, stretching exercise, Proprioceptive neuromuscular facilitation (PNF) techniques, Graduated active exercises, postural correction, gait training, balance training on different base of supports using static and dynamic balance training with reciprocal and weight shifting exercises.

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.

Group Type: EXPERIMENTAL

REHACOM Software

Intervention Type: DEVICE

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.

A Designed Physical Therapy Program

Intervention Type: OTHER

A designed physiotherapy program consisted of aerobic exercise on treadmill, stretching exercise, Proprioceptive neuromuscular facilitation (PNF) techniques, Graduated active exercises, postural correction, gait training, balance training on different base of supports using static and dynamic balance training with reciprocal and weight shifting exercises.

Interventions

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.

Intervention Type: DEVICE

A Designed Physical Therapy Program

A designed physiotherapy program consisted of aerobic exercise on treadmill, stretching exercise, Proprioceptive neuromuscular facilitation (PNF) techniques, Graduated active exercises, postural correction, gait training, balance training on different base of supports using static and dynamic balance training with reciprocal and weight shifting exercises.

Intervention Type: OTHER

Other Intervention Names

Computer-Based Cognitive Training

Eligibility Criteria

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.

• Minimum Eligible Age: 58 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Engy Badreldin Saleh Moustafa, PhD

OTHER

Sponsor Role: lead

Responsible Party

Engy Badreldin Saleh Moustafa, PhD

Dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Engy B Saleh, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Physical Therapy, Cairo University, Egypt

Locations

Faculty of Physical Therapy, Cairo University

Giza, Giza Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Engy B Saleh, PhD

Role: CONTACT

engybm.saleh@yahoo.com

00201099445112

Moshera H. Darwish, PhD

Role: CONTACT

dr.moshera11@yahoo.com

00201015163617

Facility Contacts

Engy B Saleh, PhD

Role: primary

engybm.saleh@yahoo.com

00201099445112

Moshera H. Darwish, PhD

Role: backup

dr.moshera11@yahoo.com

00201015163617

Other Identifiers

P.T.REC/012/004746

Identifier Type: -

Identifier Source: org_study_id