GPR: The Effectiveness of Global Postural Reeducation on Alzheimer Disease Patients

Sponsor
Universidad Católica San Antonio de Murcia (Other)
Overall Status
Completed
CT.gov ID
NCT03732053
Collaborator
(none)
135
2
6.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: GPR Intervention Research group
N/A

Detailed 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).

Study Design

Study Type:
Interventional
Actual Enrollment :
135 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Controlled TrialRandomized Controlled Trial
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effectiveness of Physical Rehabilitation in the Enhancement of Proprioceptive and Cognitive Aspects on Alzheimer Disease Patients
Actual Study Start Date :
Dec 5, 2016
Actual Primary Completion Date :
Mar 10, 2017
Actual Study Completion Date :
Jul 3, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: GPR Intervention Research group

A total of 135 subjects with AD in the mild or moderate phase participated in the study from which 90 pertain to research group.The intervention implemented to the patients with AD was the Global Postural therapy which lasted about 30-40 min in repeated sessions of 2 meetings per week by making 48 sessions in total during a six month period.

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

No Intervention: Control Group

45 subjects of the study belongs to the control group which has not received the same treatment .

Outcome Measures

Primary Outcome Measures

  1. Cognitive Abilities Measurement [Change from baseline cognitive evaluation at 6'th month]

    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.

Secondary Outcome Measures

  1. Quality of Life in Alzheimer's disease (QoL-AD) Questionnaire [Change from baseline cognitive evaluation at 6'th month]

    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.

  2. Geriatric Depression Scale (GDS) Questionnaire [Change from baseline cognitive evaluation at 6'th month]

    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.

  3. Barthel Index (BI) [Change from baseline cognitive evaluation at 6'th month]

    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.

  4. Neuropsychiatric Inventory (NPI) [Change from baseline cognitive evaluation at 6'th month]

    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.

  5. Tinetti Scale (TS) [Change from baseline cognitive evaluation at 6'th month]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 95 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Universidad Católica San Antonio de Murcia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jasemin Todri, PhD Candidate in Health Science, Universidad Católica San Antonio de Murcia
ClinicalTrials.gov Identifier:
NCT03732053
Other Study ID Numbers:
  • BJ8674287
First Posted:
Nov 6, 2018
Last Update Posted:
Nov 19, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2019