Gait Reeducation Program in Older Adults

European University

Status: Completed

Conditions: Balance; Abdominal; Physical Performance; Functional Capacity; Older Adults (65 Years and Older); Handgrip Strength; Gait Disorders; Sarcopenia; Calf Muscle Weakness

Treatments: Other: Experimental; Other: Active Comparator #1

Study type: Interventional

Funder types: Other

Identifiers

NCT07006584

182-2023-CIEI-FMH-USMP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

They where elegible if they were:

• 60 years or older.
• Not institutionalized.
• Scored 24 or higher on the Mini-Mental State Examination (MMSE), indicating no cognitive impairment.
• Could communicate effectively.
• Able to stand up and walk at least 10 meters unassisted
• Scored 60 or higher on the Barthel Index (indicating sufficient functional independence).

Exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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47 participants in 2 patient groups

Group A (Physical activity workshops)

Active Comparator group

Description:

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.

Treatment:

Other: Active Comparator #1

Group B (Physical activity workshops+functional gait training with SSM Fisior® program)

Experimental group

Description:

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).

Treatment:

Other: Experimental