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

NCT07208630 | Recruiting

• 1 other identifier: P.T.REC/012/005610
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Cognitive Abilities; Functional Abilities

Outcome Measures

Primary Outcomes (1)

• Change in Short Physical Performance Battery (SPPB) score

  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.

  Baseline and 4 weeks (end of treatment).

Secondary Outcomes (1)

• Change in Montreal Cognitive Assessment (MoCA) score

  Baseline and 4 weeks (end of treatment).

Study Arms (2)

IASTM on calf muscle bilaterally plus conventional treatment (strengthening and stretching exercise

EXPERIMENTAL

Device: Instrument-assisted soft tissue mobilization; Behavioral: Traditional physical therapy

control group, will receive conventional treatment

ACTIVE COMPARATOR

Behavioral: Traditional physical therapy

Interventions

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.

IASTM on calf muscle bilaterally plus conventional treatment (strengthening and stretching exercise

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.

IASTM on calf muscle bilaterally plus conventional treatment (strengthening and stretching exercise; control group, will receive conventional treatment

Eligibility Criteria

• Age: 65 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy

Giza, Egypt

RECRUITING

Central Study Contacts

Nouran Ahmed Ibrahim, lecturer

CONTACT

+201062207203; nouran-312@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of basic Science department

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: October 6, 2025
• Study Start: October 3, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)