Gait Reeducation Program in Older Adults

NCT07006584 | Completed DMC

• 1 other identifier: 182-2023-CIEI-FMH-USMP
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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 (Centro Integral del Adulto Mayor, CIAM) in Lima, Peru.

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

Outcome Measures

Primary Outcomes (1)

• Physical Performance

  Several tools have been proposed to evaluate mobility and to assess it. In this study, physical performance was measured using the Short Physical Performance Battery (SPPB), which has been validated for use in older populations. This test includes three components: balance (foot together, semi-tandem, tandem), 4-meter gait speed, and chair stand test (standing and sitting five times). The SPPB scores each timed task based on predefined thresholds, resulting in a total score ranging from 0 (worst performance) to 12 (best performance). The SPPB was designed to quickly identify the physical status of older adults by assessing lower limb functionality. Performance in these tests is strongly associated with mobility-related disability and serves as an independent predictor of short-term mortality and institutionalization. The medical community uses SPPB, among other tools, as a primary approach to detect and identifying frailty.

  Baseline and Week 12

Secondary Outcomes (6)

• Gait Speed

  Baseline and Week 12

• Calf Circumference

  Baseline and Week 12

• Abdominal Circumference

  Baseline and Week 12

• SARC-F (Strength, Ambulation, Rising from a chair, Stair climbing and history of Falling)

  Baseline and Week 12

• Handgrip Strength

  Baseline and Week 12

Study Arms (2)

Group A (Physical activity workshops)

ACTIVE COMPARATOR

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.

Other: Active Comparator #1

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

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: Experimental

Interventions

Experimental OTHER

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).

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

Active Comparator #1 OTHER

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 A (Physical activity workshops)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• They where elegible if they were:
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Comprehensive Center for Older Adults (CIAM).

Lince, Lima region, 15073, Peru

Location

Related Publications (1)

• Alegre-Tamariz J, Sanchez-Medina J, Runzer-Colmenares FM, Avila-Rodriguez C, Bermejo-Franco A, Parodi JF. Impact of a functional gait training program as a complementary strategy to improve physical function in older adults: a randomized clinical trial. BMC Geriatr. 2025 Oct 21;25(1):789. doi: 10.1186/s12877-025-06471-x.

  PMID: 41120990 DERIVED

MeSH Terms

Conditions

Mobility Limitation; Sarcopenia; Frailty

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 5, 2025
• Study Start: September 15, 2023
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PE (1)