The Effectiveness of Global Postural Reeducation on Alzheimer Disease Patients

Cognitive Decline Clinical Trial

— GPR  

Official title:

The Effectiveness of Physical Rehabilitation in the Enhancement of Proprioceptive and Cognitive Aspects on Alzheimer Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03732053
• Other study ID #: BJ8674287
• Status: Completed
• Phase: N/A
• Start date: December 5, 2016
• Est. completion date: July 3, 2017

Study information

• Verified date: November 2019
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research study is developed on an experimental design with randomized controlled intervention were participated 135 subjects with AD including 45 of the control group. It lasted 6 months with pre-post tests (T0-T1) executed before and after six months of treatment. By having in focus the evaluation of GPR therapy effects on cognitive, proprioceptive, depressive, autonomy, gait and life quality of the above mentioned subjects.

Description:

In order to assess the cognitive abilities of the patients a cognitive test was administered which acts through a scale concerning depression and mood evaluation as well as a questionnaire was developed aiming to evaluate the examined subjects' functional abilities: Mini Mental State Examination (MMSE), Quality of Life in Alzheimer Disease (QoL-AD), geriatric Depression Scale (GDS), Barthel Index (BI), Neuropsychiatric Inventory (NPI), Tinetti Scale (TS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: July 3, 2017
• Est. primary completion date: March 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 95 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Alzheimer's Disease

• Older than 40 years of age

• Male and female

• Intellectual disability

• Cognitive impairment

• Able to do daily activities on his own

• No presence of any other neurological and psychological disease

• No presence of brain tumors

Exclusion Criteria:

• No presence of Alzheimer's Disease

• Under 40 years old

• Presence of brain tumors

• Neurological patients

• Presence of psychiatric disease

• Depression symptoms

• Presence of neuromuscular disease

• Ictus

• Aggressive patients

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Type Dementia
• Cognitive Decline
• Cognitive Dysfunction
• Postural; Strain

Intervention

Other:
• GPR Intervention Research group
The research intervention consisted in the reappointment of three GPR therapeutic postures.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive Abilities Measurement	The therapeutist provides the Mini Mental State Examination (MMSE) scale records. The evaluation consits in a 0-30 points-scale. Lower scores imply the severity of dementia.	Change from baseline cognitive evaluation at 6'th month
Secondary	Quality of Life in Alzheimer's disease (QoL-AD) Questionnaire	The therapeutist measures in the begining and in the end of the study the quality of life in patients with Alzheimer's disease (QoL-AD). This questionnaire consists in 13 elements referring to the perception that patients have concerning various aspects of their life: mood, health, cognition, environment and functional capacity. The range of scores is 13-52, were higher scores indicate a better life quality.	Change from baseline cognitive evaluation at 6'th month
Secondary	Geriatric Depression Scale (GDS) Questionnaire	The version of 15 articles was used, which given its length can be validly and reliably resolved by patients themselves in the quality of a self-report questionnaire aiming to investigate the possible presence of depressive symptoms.	Change from baseline cognitive evaluation at 6'th month
Secondary	Barthel Index (BI)	This scale is used by therapist to measure the performance in the basic activities of daily life of AD patients. The maximum score used is 100 points and refers to the patient's independence in all basic daily living activities.	Change from baseline cognitive evaluation at 6'th month
Secondary	Neuropsychiatric Inventory (NPI)	This test includes 12 symptoms scored according to the phenomenon severity and frequency. It is a helpful instrument for the therapist because of specifically designed for the assessment of psycho-behavioral disorders in individuals with cognitive impairment.	Change from baseline cognitive evaluation at 6'th month
Secondary	Tinetti Scale (TS)	The therapist used the equilibrium sub-scale, which consists in 7 elements and has a score between 0 and 13. Highest scores indicate a better balance.	Change from baseline cognitive evaluation at 6'th month