StrokeSpasticityNCT06265753
Gastrocinemius Function Massage on Lower Extemity Spasticity
A study testing Gastrocinemius Function Massage in people with Stroke and Stroke Ischemic, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate gastrocinemius function massage on physical parameters of stroke patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Stroke Ischemic
- What is being tested?
- Gastrocinemius Function Massage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jan 2024to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- having experienced a stroke at least 6 months prior,
- being able to stand independently for at least 1 minute,
- scoring at least 23 on the Standardised Mini-Mental State Examination (SMMSE), indicating no significant cognitive impairment , and
- having lower extremity spasticity rated between 1-3 on the modified Asworth scale
- at least 18 years of age.
Who cannot join
- comorbidities such as neurological, orthopaedic, metabolic, and rheumatological diseases that could potentially impact soft tissues.
- patients who had received spasticity or other treatments that could affect soft tissues within the past 3 months,
- those with lower extremity injuries, and those with a diagnosis of cancer or who were pregnant.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University Address
Denizli, Muş Alparslan University, 20100
About this study
Official title: Effects of Gastrocinemius Function Massage on Lower Extemity Spasticity, Spatio- Temporal Gait Variables and Fall Risk ın Patients With Stroke
This study aimed to investigate gastrocinemius function massage on physical parameters of stroke patients.
Read the detailed description
Gastrocinemius function massage is known to relieve pain and increase range of motion. However, its effects on spasticity and physical performance in stroke patients are not fully understood. In this study, we aimed to investigate the effects of gastrocinemius function massage.
- Conditions
- Stroke, Stroke Ischemic
- Being tested
- Gastrocinemius Function Massage, Sham application
- Keywords
- Spacticity, Gastrocinemius function massage, stroke, gait
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastrocinemius Function MassageOther
The purpose of gastrocnemius massage is to alleviate muscle stiffness in the gastrocnemius muscle and enhance mobility in the foot and ankle of the individuals involved. During the GFM application, the patient assumes a prone posture on a suitable treatment bed. The therapist positions themselves behind the patient's side and secures the patient's foot between their hip and ilium.The therapist firmly holds the gastrocnemius muscle using both hands and applies pressure to the ankle, causing it to move in the direction of dorsiflexion. Simultaneously, the therapist applies mobilisation in the cranial direction, following the same path as the gastrocnemius muscle fibres, using both hands. Afterwards, the therapist gently pulls the arm and trunk backwards until the foot and gastrocnemius muscle become relaxed. The application is sustained in a rhythmic manner . We will apply this massage aproximately 10 min to experimental group.
Sham applicationOther
The sham application was conducted when the patient was lying face down, with the hands placed on the gastrocnemius muscle without any movement. We will apply this application aproximately 10 min to experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Who received 10 minutes gastrocinemius function massage and 45 minutes classic physiotherapy exercise Receives: Other: Gastrocinemius Function Massage |
| Control group | Sham comparator | Who received 10 sham applicaiton massage and 45 minutes classic physiotherapy exercise Receives: Other: Sham application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spasticity
Modified Aswort Scale is used to asses spasticity level of participants,The Muscle Assessment Scale (MAS) is a method utilised to assess the degree of resistance experienced during passive range of motion exercises. This evaluation does not necessitate any specialised equipment and can be conducted swiftly (Bohannon and Smith, 1987). The assessment of the efficacy of pharmacological and rehabilitative therapies in the treatment and management of spasticity in stroke patients is commonly employed (Ansasri et al., 2008). The scale is denoted by the subsequent numerical values (Ansasri et all., 2008). 0: Absence of increase in muscular tone 1: There is a little rise in muscle tension, accompanied by a mild resistance or moderate challenge at the furthest point of movement when flexing or extending the affected body part(s). 1+: A slight augmentation in muscular tension is succeeded by negligible opposition throughout the remaining (less than 50%) of the motion range.
Measured: aproximately 10 miutes
Gait parameters and fall risk
Spatial Temporal Gait Analysis, also known as Legsystm, is a method used to analyse the movement patterns and timing of an individual's gait. The walking variables of the subjects were assessed using a wearable walking analysis device known as Legsystm. The user's text is empty. The data gathered by two sensors affixed to the supramaleo region using Velcro is transmitted and processed to the connected computer using Bluetooth. Legsystm possesses the capacity to perform diverse measurements of spatio-temporal data obtained from people. During the Legsystm analysis, participants were instructed to perform the Time up and go test. The Timed Up and Go (TUG) test will be utilised to evaluate the spatio-temporal parameters and ascertain the likelihood of falling in stroke patients. During the TUG (Timed Up and Go) test, the patient is initially positioned in an appropriate chair.
Measured: aproximately 5 miutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start23 Jan 2024
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Model description
- In the study, 2 different groups (experimental and control) will be formed by using randomisation method. In addition to 45 minutes of classical physiotherapy exercises, 10 minutes of gastrocinemius function massage will be applied to the experimental group, while 10 minutes of sham massage and 45 minutes of classical physiotherapy exercises will be applied to the control group. The application will continue 2 days a week for 6 weeks. Spasticity, gait parameters and fall risks of the participants will be evaluated before and after the treatment with the help of various tests. Translated with www.DeepL.com/Translator (free version)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre BASKAN, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265753
- Sponsor's protocol ID
- Gastrocimemius spasticity
- Other IDs
- E-60116787-020-474196
- Acronym
- Spasticity
- Status last verified
- Feb 2024
- First submitted
- 24 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dengiz A, Sekeroz S, Baskan E, Kara G. Effects of gastrocnemius functional massage on lower extemity spasticity, spatio- temporal gait variables and fall risk in patients with stroke: A randomized controlled trial. PLoS One. 2025 Sep 24;20(9):e0332308. doi: 10.1371/journal.pone.0332308. eCollection 2025.
PubMed 40991570
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Gastrocinemius Function Massage on Lower Extemity Spasticity, Spatio- Temporal Gait Variables and Fall Risk ın Patients With Stroke
- ClinicalTrials.gov ID
- NCT06265753
- Acronym / sponsor ID
- Spasticity / Gastrocimemius spasticity
- Conditions
- Stroke, Stroke Ischemic
- Keywords
- Spacticity, Gastrocinemius function massage, stroke, gait
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 20 Feb 2024 (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.
This study aimed to investigate gastrocinemius function massage on physical parameters of stroke patients.
Detailed description
Gastrocinemius function massage is known to relieve pain and increase range of motion. However, its effects on spasticity and physical performance in stroke patients are not fully understood. In this study, we aimed to investigate the effects of gastrocinemius function massage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- In the study, 2 different groups (experimental and control) will be formed by using randomisation method. In addition to 45 minutes of classical physiotherapy exercises, 10 minutes of gastrocinemius function massage will be applied to the experimental group, while 10 minutes of sham massage and 45 minutes of classical physiotherapy exercises will be applied to the control group. The application will continue 2 days a week for 6 weeks. Spasticity, gait parameters and fall risks of the participants will be evaluated before and after the treatment with the help of various tests. Translated with www.DeepL.com/Translator (free version)
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Gastrocinemius Function MassageWho received 10 minutes gastrocinemius function massage and 45 minutes classic physiotherapy exercise |
| Control group | Sham comparator | Other: Sham applicationWho received 10 sham applicaiton massage and 45 minutes classic physiotherapy exercise |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- having experienced a stroke at least 6 months prior,
- being able to stand independently for at least 1 minute,
- scoring at least 23 on the Standardised Mini-Mental State Examination (SMMSE), indicating no significant cognitive impairment , and
- having lower extremity spasticity rated between 1-3 on the modified Asworth scale
- at least 18 years of age.
Key exclusion criteria (3 listed)
- comorbidities such as neurological, orthopaedic, metabolic, and rheumatological diseases that could potentially impact soft tissues.
- patients who had received spasticity or other treatments that could affect soft tissues within the past 3 months,
- those with lower extremity injuries, and those with a diagnosis of cancer or who were pregnant.
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 |
|---|---|---|
| Gastrocinemius Function MassageThe purpose of gastrocnemius massage is to alleviate muscle stiffness in the gastrocnemius muscle and enhance mobility in the foot and ankle of the individuals involved. During the GFM application, the patient assumes a prone posture on a suitable treatment bed. The therapist positions themselves behind the patient's side and secures the patient's foot between their hip and ilium.The therapist firmly holds the gastrocnemius muscle using both hands and applies pressure to the ankle, causing it to move in the direction of dorsiflexion. Simultaneously, the therapist applies mobilisation in the cranial direction, following the same path as the gastrocnemius muscle fibres, using both hands. Afterwards, the therapist gently pulls the arm and trunk backwards until the foot and gastrocnemius muscle become relaxed. The application is sustained in a rhythmic manner . We will apply this massage aproximately 10 min to experimental group. | Other | Experimental Group |
| Sham applicationThe sham application was conducted when the patient was lying face down, with the hands placed on the gastrocnemius muscle without any movement. We will apply this application aproximately 10 min to experimental group. | Other | Control group |
Primary outcome
Spasticity
Time frame: aproximately 10 miutes
Modified Aswort Scale is used to asses spasticity level of participants,The Muscle Assessment Scale (MAS) is a method utilised to assess the degree of resistance experienced during passive range of motion exercises. This evaluation does not necessitate any specialised equipment and can be conducted swiftly (Bohannon and Smith, 1987). The assessment of the efficacy of pharmacological and rehabilitative therapies in the treatment and management of spasticity in stroke patients is commonly employed (Ansasri et al., 2008). The scale is denoted by the subsequent numerical values (Ansasri et all., 2008). 0: Absence of increase in muscular tone 1: There is a little rise in muscle tension, accompanied by a mild resistance or moderate challenge at the furthest point of movement when flexing or extending the affected body part(s). 1+: A slight augmentation in muscular tension is succeeded by negligible opposition throughout the remaining (less than 50%) of the motion range.
Gait parameters and fall risk
Time frame: aproximately 5 miutes
Spatial Temporal Gait Analysis, also known as Legsystm, is a method used to analyse the movement patterns and timing of an individual's gait. The walking variables of the subjects were assessed using a wearable walking analysis device known as Legsystm. The user's text is empty. The data gathered by two sensors affixed to the supramaleo region using Velcro is transmitted and processed to the connected computer using Bluetooth. Legsystm possesses the capacity to perform diverse measurements of spatio-temporal data obtained from people. During the Legsystm analysis, participants were instructed to perform the Time up and go test. The Timed Up and Go (TUG) test will be utilised to evaluate the spatio-temporal parameters and ascertain the likelihood of falling in stroke patients. During the TUG (Timed Up and Go) test, the patient is initially positioned in an appropriate chair.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Derived from this study: PubMed 40991570Dengiz A, Sekeroz S, Baskan E, Kara G. Effects of gastrocnemius functional massage on lower extemity spasticity, spatio- temporal gait variables and fall risk in patients with stroke: A randomized controlled trial. PLoS One. 2025 Sep 24;20(9):e0332308. doi: 10.1371/journal.pone.0332308. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastrocinemius Function Massage in people with Stroke and Stroke Ischemic, run by Pamukkale University at 1 site in Turkey (Türkiye).
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spasticity (time frame: aproximately 10 miutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06265753, which also lists 1 linked publication.
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 20 Feb 2024; AzTrials last refreshed its copy on 28 Oct 2026.