NCT03732053

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

November 6, 2018

Completed
Last Updated

November 19, 2019

Status Verified

November 1, 2019

Enrollment Period

3 months

First QC Date

April 17, 2018

Last Update Submit

November 15, 2019

Conditions

Alzheimer's Type DementiaCognitive DeclinePostural; Strain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Quality of Life in Alzheimer's disease (QoL-AD) Questionnaire

    Change from baseline cognitive evaluation at 6'th month

  • Geriatric Depression Scale (GDS) Questionnaire

    Change from baseline cognitive evaluation at 6'th month

  • Barthel Index (BI)

    Change from baseline cognitive evaluation at 6'th month

  • Neuropsychiatric Inventory (NPI)

    Change from baseline cognitive evaluation at 6'th month

  • Tinetti Scale (TS)

    Change from baseline cognitive evaluation at 6'th month

Study Arms (2)

GPR Intervention Research group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

GPR Intervention Research groupOTHER

The research intervention consisted in the reappointment of three GPR therapeutic postures.

GPR Intervention Research group

Eligibility Criteria

Age40 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Todri J, Lena O, Todri A, Fuentes JM. Does the Global Postural Re-Education Affect the Psychological and Postural Aspects of Alzheimer Disease Patients? A Six Months Quasi-Experimental Study. Curr Alzheimer Res. 2021;18(13):1057-1065. doi: 10.2174/1567205019666211223094811.

    PMID: 34951386DERIVED

MeSH Terms

Conditions

Cognitive DysfunctionSprains and Strains

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate in Health Science

Study Record Dates

First Submitted

April 17, 2018

First Posted

November 6, 2018

Study Start

December 5, 2016

Primary Completion

March 10, 2017

Study Completion

July 3, 2017

Last Updated

November 19, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

All participants signed the informed consent and their family members were also informed concerning the purpose of the study. Correspondingly the data were provided by the physiotherapists who performed the above mentioned technique. Thereafter the study was validated and approved by the Ethics Committee of Catholic University of Murcia.