Trials / Completed

CompletedNCT07006584

Gait Reeducation Program in Older Adults

Impact of a Functional Gait Training Program as a Complementary Strategy to Improve Physical Function in Older Adults

Status: Completed
Phase: N/A
Study type: Interventional
Enrollment: 47 (actual)

Sponsor: Universidad Europea de Madrid · Academic / Other
Sex: All
Age: 60 Years
Healthy volunteers: Not accepted

Summary

The sequential square mat (SSM) Fisior® program is a novel functional gait training tool designed to enhance motor control, coordination, and strength through guided step sequences on a visual-tactile platform. The objective of the present study is to evaluate the effects of incorporating the SSM Fisior® gait training program into routine physical activity workshops for older adults. Specifically, the study aims to assess its impact on skeletal muscle quantity, strength, and performance, as well as overall functional capacity, in a population of older adults attending a municipal community center (Centro Integral del Adulto Mayor, CIAM) in Lima, Peru.

Detailed description

The present study is a randomized was carried out with adults aged 60 years and older recruited from the Comprehensive Center for Older Adults (CIAM) in the Lince district of Lima, Peru. The study adhered to the ethical principles outlined in the Declaration of Helsinki, and its protocol (182-2023-CIEI-FMH-USMP) received approval from the Institutional Ethics Committee of the Faculty of Human Medicine at the University of San Martín de Porres (USMP), Lima, Peru. Participants were eligible if they were 60 years or older, were not institutionalized, scored 24 or higher on the Mini-Mental State Examination (MMSE), indicating no cognitive impairment, could communicate effectively, were able to stand up and walk at least 10 meters unassisted, scored 60 or higher on the Barthel Index (indicating sufficient functional independence). Furthermore, participants were excluded if they had a medical condition that contraindicated gait training and exhibited severe cognitive or behavioral impairments that would prevent them from completing the training program. A simple randomization process was used to assign participants to two groups: Group A and Group B. The randomization was performed using a computer-generated random number sequence with Microsoft Excel, and it was conducted after participant enrollment to ensure allocation concealment. Group A attended only the physical activity workshops offered by Centro Integral del Adulto Mayor (CIAM), consisting of one weekly class each of gymnastics, dance, swimming, and Tai Chi, held on different days of the week. Group B participated in the same workshops and additionally completed functional gait training using the SSM Fisior® program. The intervention period lasted 12 weeks for both groups, with 2 additional weeks allocated for baseline and post-intervention assessments (T1 and T2). All assessments and activities were carried out at the CIAM center in Lince (Lima, Peru), between October and December 2023.

Conditions

Interventions

Type	Name	Description
OTHER	Experimental	Group B participated in the same workshops and additionally completed functional gait training using the SSM Fisior® program. The intervention period lasted 12 weeks for both groups, with 2 additional weeks allocated for baseline and post-intervention assessments (T1 and T2).
OTHER	Active Comparator #1	Group A attended only the physical activity workshops offered by Centro Integral del Adulto Mayor (CIAM), consisting of one weekly class each of gymnastics, dance, swimming, and Tai Chi, held on different days of the week.

Timeline

Start date: 2023-09-15
Primary completion: 2023-10-31
Completion: 2023-10-31
First posted: 2025-06-05
Last updated: 2025-07-24

Locations

1 site across 1 country: Peru

Source: ClinicalTrials.gov record NCT07006584. Inclusion in this directory is not an endorsement.