Functional AbilitiesIASTM-AGENCT07208630
Effect of Instrument-assisted Soft Tissue Mobilization on Functional and Cognitive Abilities in Elderly
A study testing Instrument-assisted soft tissue mobilization and Traditional physical therapy in people with Functional Abilities and Cognitive Abilities, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Abilities, Cognitive Abilities
- What is being tested?
- Instrument-assisted soft tissue mobilization and Traditional physical therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Oct 2025to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- They neither had sever musculoskeletal disorders
- Nor neurological damage related to balance (dizziness, vestibular dysfunction)
- Nor orthostatic hypotension
- Nor health risk factors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of physical therapy
Giza
Nouran Ahmed Ibrahim, lecturer, +201062207203, nouran-312@cu.edu.eg
Nouran, nornor-312@hotmail.com
About this study
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.
Read more
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
- Functional Abilities, Cognitive Abilities
- Being tested
- Instrument-assisted soft tissue mobilization, Traditional physical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument-assisted soft tissue mobilizationDevice
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 therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| IASTM on calf muscle bilaterally plus conventional treatment (strengthening and stretching exercise | Experimental | Not described Receives: Device: Instrument-assisted soft tissue mobilization; Behavioral: Traditional physical therapy |
| control group, will receive conventional treatment | Active comparator | Not described Receives: Behavioral: Traditional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 4 weeks (end of treatment).
Secondary outcomes (1)
Change in Montreal Cognitive Assessment (MoCA) score
Mean change in MoCA total score (0-30; higher = better cognition) from baseline to end of intervention and at follow-up.
Measured: Baseline and 4 weeks (end of treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start3 Oct 2025
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional AbilitiesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouran Ahmed Ibrahim, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208630
- Sponsor's protocol ID
- P.T.REC/012/005610
- Acronym
- IASTM-AGE
- Status last verified
- Feb 2026
- First submitted
- 28 Sep 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Instrument-assisted Soft Tissue Mobilization on Functional and Cognitive Abilities in Elderly
- ClinicalTrials.gov ID
- NCT07208630
- Acronym / sponsor ID
- IASTM-AGE / P.T.REC/012/005610
- Conditions
- Functional Abilities, Cognitive Abilities
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Oct 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- They neither had sever musculoskeletal disorders
- Nor neurological damage related to balance (dizziness, vestibular dysfunction)
- Nor orthostatic hypotension
- Nor health risk factors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instrument-assisted soft tissue mobilizationIASTM 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. | Device | IASTM on calf muscle bilaterally plus conventional treatment (strengthening and stretching exercise |
| Traditional physical therapyThe 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. | Behavioural | IASTM on calf muscle bilaterally plus conventional treatment (strengthening and stretching exercise, control group, will receive conventional treatment |
Primary outcome
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.
1 secondary outcome
Change in Montreal Cognitive Assessment (MoCA) score
Time frame: Baseline and 4 weeks (end of treatment).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instrument-assisted soft tissue mobilization and Traditional physical therapy in people with Functional Abilities and Cognitive Abilities, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nouran Ahmed Ibrahim, lecturer (+201062207203, nouran-312@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Short Physical Performance Battery (SPPB) score (time frame: Baseline and 4 weeks (end of treatment).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.