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NCT Number: NCT07208630

Effect of Instrument-assisted Soft Tissue Mobilization on Functional and Cognitive Abilities in Elderly

PURPOSE: To determine the effect of Instrument-assisted soft tissue mobilization on functional and cognitive abilities in elderly.

BACKGROUND: There is an increased interest in health care with growth of the older population.

Instrument-Assisted Soft Tissue Mobilization (IASTM) is a manual therapy technique using specially designed tools to apply pressure and mobilize soft tissues. It has gained attention as a non-invasive intervention that can aid in improving musculoskeletal health and overall function, especially in older adults. Given the aging population and the rise in age-related functional and cognitive decline, there is a pressing need for effective strategies to enhance quality of life in this demographic.

In the elderly, musculoskeletal issues, such as reduced muscle flexibility, joint stiffness, and soft tissue restrictions, are common and can severely impact physical function. IASTM has been shown to increase tissue perfusion, reduce fascial restrictions, and improve joint mobility. These effects are critical in countering age-related declines in mobility, balance, and overall physical functionality, ultimately promoting greater independence and reducing fall risk. Improved physical function through IASTM may also influence cognitive health positively, as increased physical activity and mobility are linked to better cognitive outcomes in the elderly.

HYPOTHESES: There will be no significant effect of Instrument-assisted soft tissue mobilization on functional and cognitive abilities in elderly.

RESEARCH QUESTION: Does instrument-assisted soft tissue mobilization is effective on functional and cognitive abilities in elderly?

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Key information

Conditions

Functional Abilities Cognitive Abilities

Age range

65 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 60 elderly subjects aged range from 65-75 years old will participant in the study from both genders.
  • had cognitive abilities to understand explanations and instructions
  • did not take any medication that can affect their balance.

Exclusion criteria

  • They neither had sever musculoskeletal disorders
  • Nor neurological damage related to balance (dizziness, vestibular dysfunction)
  • Nor orthostatic hypotension
  • Nor health risk factors.

Treatment and study plan

Instrument-Assisted Soft Tissue Mobilization

Device

IASTM will be delivered using stainless-steel instruments with beveled edges, applied to the target muscle groups for approximately 20 minutes per session, two times per week, over four weeks. A licensed physical therapist trained in IASTM will perform the procedure. Lubricant will be applied to the skin, and strokes will be delivered in multiple directions with pressure adapted to patient tolerance.

Traditional physical therapy

Behavioral

The control group will receive a traditional physical therapy program focusing on strength, balance, flexibility, and functional mobility training, combined with simple cognitive stimulation tasks. Sessions will last 30 minutes, two times per week, for four weeks, supervised by a licensed physical therapist.

Primary outcomes

  1. Change in Short Physical Performance Battery (SPPB) score

    Time frame: Baseline and 4 weeks (end of treatment).

    Mean change in SPPB total score (0-12; higher = better physical function) from baseline to end of intervention. The SPPB includes standing balance, 4-m gait speed, and five-times-sit-to-stand.

Secondary outcomes

  1. Change in Montreal Cognitive Assessment (MoCA) score

    Time frame: Baseline and 4 weeks (end of treatment).

    Mean change in MoCA total score (0-30; higher = better cognition) from baseline to end of intervention and at follow-up.

Study contacts

Contact information is provided by the study sponsor or research team.

Nouran Ahmed Ibrahim, lecturer

CONTACT

[email protected]

+201062207203

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Acronym: IASTM-AGE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 6, 2025
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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