Clinical trial NCT07006584: Gait Reeducation Program in Older Adults
Official title: Impact of a Functional Gait Training Program as a Complementary Strategy to Improve Physical Function in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Older Adults (65 Years and Older)
Balance
Gait Disorders
Physical Performance
Calf Muscle Weakness
Abdominal
Sarcopenia
Handgrip Strength
Functional Capacity
Keywords: Frailty
Aged
Mobility
Physical Performance
Healthy Aging
Physical Therapy
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 47
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Physical Performance
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Gait Speed
timeFrame: Baseline and Week 12
measure: Calf Circumference
timeFrame: Baseline and Week 12
measure: Abdominal Circumference
timeFrame: Baseline and Week 12
measure: SARC-F
timeFrame: Baseline and Week 12
measure: Handgrip Strength
timeFrame: Baseline and Week 12
measure: Functional Capacity: Barthel Index
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Lince
country: Peru
facility: Comprehensive Center for Older Adults (CIAM).
state: Lima
Study officials:
References: