StrokeSSUNNCT07589855
Somatosensory Stimulation for Unilateral Neglect Post Stroke (SSUN)
A study testing Mobilization and Tactile Stimulation (MTS) in people with Stroke and Unilateral Neglect Syndrome, run by Keele University at 1 site in United Kingdom.
Trial summary
The Intervention, called Mobilization and tactile Stimulation (MTS for short) is a hands-on physical therapy technique that can be used to treat the arm and hand after a stroke. It includes joint movements, massage, and sensory input like touch and compression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Unilateral Neglect Syndrome
- What is being tested?
- Mobilization and Tactile Stimulation (MTS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Oct 2025to 1 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (≥18 years of age) who is an Adult stroke survivors (≥18 years of age) with a clinical diagnosis of UN, in the subacute-chronic phase of stroke (≥20 weeks post stroke)
- Ability to consent to participate in the study, assessed by their understanding of the study when it is explained to them.
- Sufficient cognitive and physical ability to allow inclusion in this study, assessed by the ability to follow a simple one-stage command with the non-paretic limb.
- Able and willing to receive and engage with regular therapy (MTS) (e.g. at home).
Who cannot join
- Stroke survivor with major communication problems (e.g receptive aphasia) that affect their understanding of the treatment, their ability to follow instruction, or ability to consent to participate.
- Participants who do not speak/understand English and who do not have access to an interpreter.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maryam H Mohammad contact
United Kingdom1 site, 1 recruiting
- Recruiting
Midlands Partnership University NHS Foundation Trust
Newcastle-under-Lyme, ST55 7NJ
Margurite O'Mara, Bsc, 01782 673721, Margurite.O'Mara@mpft.nhs.uk
Maryam Mohammad, m.h.mohammad@keele.ac.uk
About this study
Official title: Mobilization and Tactile Stimulation (MTS) to Improve Unilateral Neglect Post Stroke: a Pilot and Feasibility Study
The Intervention, called Mobilization and tactile Stimulation (MTS for short) is a hands-on physical therapy technique that can be used to treat the arm and hand after a stroke. It includes joint movements, massage, and sensory input like touch and compression. MTS is part of routine therapy for stroke patients when people cannot move or feel their arm normally. It may help with problems like neglect, which is when people are not aware of one side of their body after their stroke. The effectiveness of MTS to help people with neglect has not been widely studied yet.
the investigators plan to invite adult stroke patients (18 years and over) with signs of neglect, who are more than 20 weeks post-stroke to be part of this study. They must be willing to have regular therapy at home, and each participant will need to have a carer who can assist with the research.
Read more
Participants will be in the study for approximately three months. In the first two weeks they will not receive the MTS treatment but will have some regular measures undertaken (see details below). This is called the baseline Phase A stage.
Then they move to Phase B where the investigators will deliver MTS therapy for 45-60 minutes, five days a week for six weeks. This is the treatment phase, known as Phase B. The regular measures will also continue during Phase B.
Once the six weeks of MTS treatment is completed there is a final stage for two weeks (also known as Phase A because there is no treatment delivered). This is the withdrawal phase. The regular measures will continue during this phase.
To see if the MTS has any impact on the stroke survivors the investigators will take regular measurements. The investigators will be using three different assessments for neglect.
- The Letter Cancellation Test. The investigators will ask participants to cross out target letters from a sheet with various letters on it.
- The Catherine Bergego Scale (CBS). This is a 10-item checklist where a therapist or carer observes daily activities and scores the stroke survivor doing everyday activities e.g., brushing your hair and eating.
- The Fluff Test. In this test participants will be blindfolded and then asked to remove stickers from their body using their non-affected hand.
During the study, participants will be assessed by a research therapist twice a week using the three tests. Carers will be trained to use the CBS and will also conduct daily assessments.
After the 10 weeks is completed, the participant will be invited to share your experiences with us in an interview. This will help us understand better whether anything has changed because of being in this study.
MTS is commonly used in clinical practice and has a low risk of side effects. There is a small risk of overuse syndrome, which can cause arm discomfort, but this can be managed by adjusting the therapy. While the investigators cannot guarantee direct benefits to participants, clinicians that investigators spoke to told us they thought the extra treatment could be beneficial for stroke survivors.
Read the detailed description
MTS is a module of current routine therapy for the treatment of the contralesional Upper Limb (UL) after a stroke. It involves hands-on physical therapy techniques that provide somatosensory stimulation (specifically touch and proprioception) of the hand and forearm: joint mobilization (passive movements, accessory movements through anatomical range); massage and soft tissue mobilisation/stretch; specific sensory input (e.g. compression, touch including textures); and isolated / selective joint movement including placing the hand.
MTS is commonly used to treat UL complications after stroke such as limitation or loss of range of motion, and loss of sensation. MTS has also been reported to be used in the treatment of perceptual problems such as unilateral neglect (UN), which is defined as cognitive disorder that affects the ability to attend and respond to stimuli, including visual, somatosensory, and auditory stimuli, presented in the contralesional hemispace following brain lesion, like stroke, following stroke. However, UN was not formally assessed with a valid and reliable outcome measure but was based on the therapist's subjective assessment and observation of ADL and communication. As a result, research evaluating the effect of MTS on UN after stroke using valid and reliable tests of UN is warranted.
The design of this study will be a mixed methods feasibility study involving quasi-experimental, single- system (n=1) studies with A-B-A design and qualitative semi- structured interview or group interview, where appropriate . In the A-B-A design, the first A phase represents the baseline phase for comparison with subsequent phases (e.g., no intervention). Initial outcome measures are recorded at regular intervals in this phase and the participant's performance should be stable. The B phase acts as the intervention phase, and the final A phase is the withdrawal phase (i.e., no intervention). Throughout all the phases, outcome measurements are recorded regularly. In the B (intervention) phase, the researcher will deliver the MTS intervention to the participants' hemiparetic UL for 45-60 minutes daily, on five days per week, for six weeks. This dose was chosen because an average daily MTS dose of between 37 and 66 minutes was found to be suitable for subsequent evaluation in a dose-response MTS study, and this is the evidence-based dose used in previous MTS studies. The researcher will deliver MTS to the participant at their home or in an appropriate hospital-based room if this was more convenient for the participant and the content and duration of each session will be noted on a treatment schedule.
The single system ABA design selected is believed to be the most appropriate design for many reasons. Firstly, it allows detailed examination of individual responses to the intervention as well as offering distinctive perspectives on treatment responses that might not be visible in a group study. Additionally, using single system design studies is especially helpful in modelling early therapy evaluation, and assessing complex behaviour, such as those found following stroke. It is especially useful for therapists when assessing or investigating the effectiveness of a treatment. Some disorders are not suitable for evaluation through RCTs due to the difficulty in finding a large, homogeneous sample of patients. In such cases, a single-system design is appropriate. It is known that UN is characterised by heterogeneous symptoms and patients may present with different types of UN. Given the heterogeneity of the syndrome and the difficulties in recruiting a large homogeneous sample, the study of UN behaviour in patients with stroke and their response to the intervention lends itself to evaluation by a single-system design study. Finally, this design has been adopted successfully in the other literature exploring effects of limb activation on UN treatment.
In the semi-structured or group interviews, which will be conducted by a member of the research team, participants and carers will be asked to provide their feedback and opinion on various topics including: the intervention (MTS), challenges they faced, changes they noticed and acceptability of carer-collected outcome measures. If the participants or carers do not want to take part in a group interview, or there are no other participants available at that time, a separate interview will be arranged.
Topics of discussion with the participants in an interview will specifically include:
- Acceptability of the intervention: dose/frequency/comfort.
- Acceptability of the therapist coming to their home daily.
- Challenges/ barriers to completion they faced during the research study.
- Changes observed (perceived benefits).
Topics of discussion with the carers in an interview will include:
- Acceptability of carer-collected outcome measures: daily collection/ training
- Challenges/ barriers experienced in outcome measure's daily collection
- Acceptability of the frequency of MTS.
- Changes observed in participants. The interview will take place shortly after completion of the ABA study with each participant. If two participants begin and end the study at the same time, a group interviews will be offered and conducted including two participants and two carers (i.e. one group interview with two participants, and one group interview with two carers); however, if there is only one participant (and, if appropriate, the carer), a single semi structured interview will be conducted with the participant and, if appropriate,the carer The semi-structured interview or group interviews (if appropriate) will be conducted either in person or online depending on participants/ carers preference.
The design of the qualitative part of the study was chosen as a semi-structured interview for a number of reasons. Firstly, interviews are known to be a useful means of gathering people's opinions and experiences, which is one of the secondary aims of this research study. Both open and close ended questions will be asked to participants and carers on topics related to MTS dose (intensity, frequency, and duration), and comfort and outcome measure to ultimately assess the feasibility and acceptability of MTS, which emphasises the use of a semi-structured interview as a method of data collection.
- Conditions
- Stroke, Unilateral Neglect Syndrome
- Being tested
- Mobilization and Tactile Stimulation (MTS)
- Keywords
- Stroke, Unilateral neglect, inattention, somatosensory stimulation, sensory stimulation, Mobilization and Tactile Stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilization and Tactile Stimulation (MTS)Other
Mobilisation and tactile stimulation is a module of current routine therapy for the treatment of the contralesional UL after a stroke (Hunter et al., 2006). It involves hands-on physical therapy techniques that provide somatosensory stimulation (specifically touch and proprioception) of the hand and forearm: joint mobilisation (passive movements, accessory movements through anatomical range), massage and soft tissue mobilisation/stretch, specific sensory input (e.g. compression, touch including textures), and isolated / selective joint movement including placing the hand and facilitation of patterns of co-ordinated movement underlying functional activity (Hunter et al., 2006). The components of MTS are delivered to the UL in an appropriate combination based on the clinical judgement of the therapist, depending on each patient's presentation (Hunter et al., 2006).
| Study group | Role | What they receive |
|---|---|---|
| MTS intervention | Experimental | Mobilization and Tactile stimulation (MTS) delivered 5x a week for 45min each time for 6 weeks Receives: Other: Mobilization and Tactile Stimulation (MTS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluff Test
In the Fluff test (Cocchini et al., 2011), participants are asked, while blindfolded, to detach 24 stickers stuck to the left side of their body or front of their clothes, using their ipsilesional/nonparetic hand. The 24 stickers are identical circles made of white cardboard 2cm in diameter, with Velcro on one side to attach the sticker to the clothes. The patient is seated with their eyes closed / blindfolded and the stickers are attached to their clothes by the assessor . Once the stickers are all attached (three on each side of the anterior trunk, six on the anterior aspect of each leg, and six on the anterior aspect of the neglected arm) the patient is asked to remove them. There are no time restrictions and the test finishes when the patient collects or reports that all the stickers have been removed.
Measured: 10 minutes
letter cancelation test
In the letter cancellation test, which is part of behavioural inattention test (BIT) (Halligan et al., 1991) patients are seated at a table and asked to allocate a target on a sheet of paper placed on a table in front of them and cross it out from a background of different letters. It consists of 34 upper case letters and 40 targets evenly distributed on both sides of the page. The maximum score is 40 and the total number of target letters omitted is calculated and their location is determined (Plummer et al., 2003).
Measured: 5 minutes
Catherine Bergego Scale
The CBS (Azouvi,1996), which involves a 10-item checklist used by the therapist or by the carer to observe and evaluate the presence as well as the severity of UN in the personal, peri-personal, and extra-personal space, will also be used in this study. It requires a 30-minute direct observation of the stroke survivor in 10 everyday activities like grooming or shaving the left part of the face, eating food on a plate, mouth cleaning, gaze orientation and knowledge of left sided parts of the body. UN is scored on a 4-point scale: mild (1), moderate (2), severe (3), or absent (0). A total score ranging from 0 to 30 is obtained with 0 = no behavioural neglect, 1-10 = mild behavioural neglect, 11-20 = moderate behavioural neglect, 21-30 = severe behavioural neglect.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start20 Oct 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Not applicable
- Intervention model
- Single group
- Model description
- Mixed methods feasibility study involving quasi-experimental, single- system (n=1) studies with A-B-A design and qualitative semi- structured interview or group interview, where appropriate.
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keele University
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Ali Aries, PhD, Study chair, Keele University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589855
- Sponsor's protocol ID
- RG-0405-25
- Acronym
- SSUN
- Status last verified
- May 2026
- First submitted
- 27 Apr 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The complete identifiable dataset will not be made publicly accessible in order to meet GDPR requirements, protect confidentiality, and comply with institutional policies. Instead, anonymised or aggregated data may be shared through publications, conference presentations, or research repositories.
Publications
Robertson H, Hogg K, McMillan M. (1998) Rehabilitation of unilateral neglect: improving function by contralesional limb activation. Neuropsychological Rehabilitation, 8(1): 19-29.
Bailey MJ, Riddoch MJ, Crome P. Treatment of visual neglect in elderly patients with stroke: a single-subject series using either a scanning and cueing strategy or a left-limb activation strategy. Phys Ther. 2002 Aug;82(8):782-97.
PubMed 12147008Winter JM, Crome P, Sim J, Hunter SM. Effects of mobilization and tactile stimulation on chronic upper-limb sensorimotor dysfunction after stroke. Arch Phys Med Rehabil. 2013 Apr;94(4):693-702. doi: 10.1016/j.apmr.2012.11.028. Epub 2012 Nov 28.
PubMed 23201425Williams LJ, Kernot J, Hillier SL, Loetscher T. Spatial Neglect Subtypes, Definitions and Assessment Tools: A Scoping Review. Front Neurol. 2021 Nov 24;12:742365. doi: 10.3389/fneur.2021.742365. eCollection 2021.
PubMed 34899565Sim, J, Wright CH. (2000) Research in Health Care: Concepts, Designs and Methods. Cheltenham: Stanley Thornes.
Hunter SM, Hammett L, Ball S, Smith N, Anderson C, Clark A, Tallis R, Rudd A, Pomeroy VM. Dose-response study of mobilisation and tactile stimulation therapy for the upper extremity early after stroke: a phase I trial. Neurorehabil Neural Repair. 2011 May;25(4):314-22. doi: 10.1177/1545968310390223. Epub 2011 Jan 31.
PubMed 21282528Hunter SM, Crome P, Sim J, Donaldson C, Pomeroy VM. (2006) Development of treatment schedules for research: a structured review to identify methodologies used and a worked example of 'mobilisation and tactile stimulation' for stroke patients. Clinical Rehabilitation, 92(4): 195-207.
Barlow D, Hersen M. (1984) Single case experimental designs: strategies for studying behavior change. Second Edition. New York: Pergamon Press.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobilization and Tactile Stimulation (MTS) to Improve Unilateral Neglect Post Stroke: a Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT07589855
- Acronym / sponsor ID
- SSUN / RG-0405-25
- Conditions
- Stroke, Unilateral Neglect Syndrome
- Keywords
- Stroke, Unilateral neglect, inattention, somatosensory stimulation, sensory stimulation, Mobilization and Tactile Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Keele UniversityUniversity, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Study start
- 20 Oct 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 15 May 2026 (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.
The Intervention, called Mobilization and tactile Stimulation (MTS for short) is a hands-on physical therapy technique that can be used to treat the arm and hand after a stroke. It includes joint movements, massage, and sensory input like touch and compression. MTS is part of routine therapy for stroke patients when people cannot move or feel their arm normally. It may help with problems like neglect, which is when people are not aware of one side of their body after their stroke. The effectiveness of MTS to help people with neglect has not been widely studied yet.
the investigators plan to invite adult stroke patients (18 years and over) with signs of neglect, who are more than 20 weeks post-stroke to be part of this study. They must be willing to have regular therapy at home, and each participant will need to have a carer who can assist with the research.
Participants will be in the study for approximately three months. In the first two weeks they will not receive the MTS treatment but will have some regular measures undertaken (see details below). This is called the baseline Phase A stage.
Then they move to Phase B where the investigators will deliver MTS therapy for 45-60 minutes, five days a week for six weeks. This is the treatment phase, known as Phase B. The regular measures will also continue during Phase B.
Once the six weeks of MTS treatment is completed there is a final stage for two weeks (also known as Phase A because there is no treatment delivered). This is the withdrawal phase. The regular measures will continue during this phase.
To see if the MTS has any impact on the stroke survivors the investigators will take regular measurements. The investigators will be using three different assessments for neglect.
- The Letter Cancellation Test. The investigators will ask participants to cross out target letters from a sheet with various letters on it.
- The Catherine Bergego Scale (CBS). This is a 10-item checklist where a therapist or carer observes daily activities and scores the stroke survivor doing everyday activities e.g., brushing your hair and eating.
- The Fluff Test. In this test participants will be blindfolded and then asked to remove stickers from their body using their non-affected hand.
During the study, participants will be assessed by a research therapist twice a week using the three tests. Carers will be trained to use the CBS and will also conduct daily assessments.
After the 10 weeks is completed, the participant will be invited to share your experiences with us in an interview. This will help us understand better whether anything has changed because of being in this study.
MTS is commonly used in clinical practice and has a low risk of side effects. There is a small risk of overuse syndrome, which can cause arm discomfort, but this can be managed by adjusting the therapy. While the investigators cannot guarantee direct benefits to participants, clinicians that investigators spoke to told us they thought the extra treatment could be beneficial for stroke survivors.
Detailed description
MTS is a module of current routine therapy for the treatment of the contralesional Upper Limb (UL) after a stroke. It involves hands-on physical therapy techniques that provide somatosensory stimulation (specifically touch and proprioception) of the hand and forearm: joint mobilization (passive movements, accessory movements through anatomical range); massage and soft tissue mobilisation/stretch; specific sensory input (e.g. compression, touch including textures); and isolated / selective joint movement including placing the hand.
MTS is commonly used to treat UL complications after stroke such as limitation or loss of range of motion, and loss of sensation. MTS has also been reported to be used in the treatment of perceptual problems such as unilateral neglect (UN), which is defined as cognitive disorder that affects the ability to attend and respond to stimuli, including visual, somatosensory, and auditory stimuli, presented in the contralesional hemispace following brain lesion, like stroke, following stroke. However, UN was not formally assessed with a valid and reliable outcome measure but was based on the therapist's subjective assessment and observation of ADL and communication. As a result, research evaluating the effect of MTS on UN after stroke using valid and reliable tests of UN is warranted.
The design of this study will be a mixed methods feasibility study involving quasi-experimental, single- system (n=1) studies with A-B-A design and qualitative semi- structured interview or group interview, where appropriate . In the A-B-A design, the first A phase represents the baseline phase for comparison with subsequent phases (e.g., no intervention). Initial outcome measures are recorded at regular intervals in this phase and the participant's performance should be stable. The B phase acts as the intervention phase, and the final A phase is the withdrawal phase (i.e., no intervention). Throughout all the phases, outcome measurements are recorded regularly. In the B (intervention) phase, the researcher will deliver the MTS intervention to the participants' hemiparetic UL for 45-60 minutes daily, on five days per week, for six weeks. This dose was chosen because an average daily MTS dose of between 37 and 66 minutes was found to be suitable for subsequent evaluation in a dose-response MTS study, and this is the evidence-based dose used in previous MTS studies. The researcher will deliver MTS to the participant at their home or in an appropriate hospital-based room if this was more convenient for the participant and the content and duration of each session will be noted on a treatment schedule.
The single system ABA design selected is believed to be the most appropriate design for many reasons. Firstly, it allows detailed examination of individual responses to the intervention as well as offering distinctive perspectives on treatment responses that might not be visible in a group study. Additionally, using single system design studies is especially helpful in modelling early therapy evaluation, and assessing complex behaviour, such as those found following stroke. It is especially useful for therapists when assessing or investigating the effectiveness of a treatment. Some disorders are not suitable for evaluation through RCTs due to the difficulty in finding a large, homogeneous sample of patients. In such cases, a single-system design is appropriate. It is known that UN is characterised by heterogeneous symptoms and patients may present with different types of UN. Given the heterogeneity of the syndrome and the difficulties in recruiting a large homogeneous sample, the study of UN behaviour in patients with stroke and their response to the intervention lends itself to evaluation by a single-system design study. Finally, this design has been adopted successfully in the other literature exploring effects of limb activation on UN treatment.
In the semi-structured or group interviews, which will be conducted by a member of the research team, participants and carers will be asked to provide their feedback and opinion on various topics including: the intervention (MTS), challenges they faced, changes they noticed and acceptability of carer-collected outcome measures. If the participants or carers do not want to take part in a group interview, or there are no other participants available at that time, a separate interview will be arranged.
Topics of discussion with the participants in an interview will specifically include:
- Acceptability of the intervention: dose/frequency/comfort.
- Acceptability of the therapist coming to their home daily.
- Challenges/ barriers to completion they faced during the research study.
- Changes observed (perceived benefits).
Topics of discussion with the carers in an interview will include:
- Acceptability of carer-collected outcome measures: daily collection/ training
- Challenges/ barriers experienced in outcome measure's daily collection
- Acceptability of the frequency of MTS.
- Changes observed in participants. The interview will take place shortly after completion of the ABA study with each participant. If two participants begin and end the study at the same time, a group interviews will be offered and conducted including two participants and two carers (i.e. one group interview with two participants, and one group interview with two carers); however, if there is only one participant (and, if appropriate, the carer), a single semi structured interview will be conducted with the participant and, if appropriate,the carer The semi-structured interview or group interviews (if appropriate) will be conducted either in person or online depending on participants/ carers preference.
The design of the qualitative part of the study was chosen as a semi-structured interview for a number of reasons. Firstly, interviews are known to be a useful means of gathering people's opinions and experiences, which is one of the secondary aims of this research study. Both open and close ended questions will be asked to participants and carers on topics related to MTS dose (intensity, frequency, and duration), and comfort and outcome measure to ultimately assess the feasibility and acceptability of MTS, which emphasises the use of a semi-structured interview as a method of data collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Mixed methods feasibility study involving quasi-experimental, single- system (n=1) studies with A-B-A design and qualitative semi- structured interview or group interview, where appropriate.
| Arm | Type | Receives |
|---|---|---|
| MTS intervention | Experimental | Other: Mobilization and Tactile Stimulation (MTS)Mobilization and Tactile stimulation (MTS) delivered 5x a week for 45min each time for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (≥18 years of age) who is an Adult stroke survivors (≥18 years of age) with a clinical diagnosis of UN, in the subacute-chronic phase of stroke (≥20 weeks post stroke)
- Ability to consent to participate in the study, assessed by their understanding of the study when it is explained to them.
- Sufficient cognitive and physical ability to allow inclusion in this study, assessed by the ability to follow a simple one-stage command with the non-paretic limb.
- Able and willing to receive and engage with regular therapy (MTS) (e.g. at home).
Key exclusion criteria (2 listed)
- Stroke survivor with major communication problems (e.g receptive aphasia) that affect their understanding of the treatment, their ability to follow instruction, or ability to consent to participate.
- Participants who do not speak/understand English and who do not have access to an interpreter.
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 |
|---|---|---|
| Mobilization and Tactile Stimulation (MTS)Mobilisation and tactile stimulation is a module of current routine therapy for the treatment of the contralesional UL after a stroke (Hunter et al., 2006). It involves hands-on physical therapy techniques that provide somatosensory stimulation (specifically touch and proprioception) of the hand and forearm: joint mobilisation (passive movements, accessory movements through anatomical range), massage and soft tissue mobilisation/stretch, specific sensory input (e.g. compression, touch including textures), and isolated / selective joint movement including placing the hand and facilitation of patterns of co-ordinated movement underlying functional activity (Hunter et al., 2006). The components of MTS are delivered to the UL in an appropriate combination based on the clinical judgement of the therapist, depending on each patient's presentation (Hunter et al., 2006). | Other | MTS intervention |
Primary outcome
Fluff Test
Time frame: 10 minutes
In the Fluff test (Cocchini et al., 2011), participants are asked, while blindfolded, to detach 24 stickers stuck to the left side of their body or front of their clothes, using their ipsilesional/nonparetic hand. The 24 stickers are identical circles made of white cardboard 2cm in diameter, with Velcro on one side to attach the sticker to the clothes. The patient is seated with their eyes closed / blindfolded and the stickers are attached to their clothes by the assessor . Once the stickers are all attached (three on each side of the anterior trunk, six on the anterior aspect of each leg, and six on the anterior aspect of the neglected arm) the patient is asked to remove them. There are no time restrictions and the test finishes when the patient collects or reports that all the stickers have been removed.
letter cancelation test
Time frame: 5 minutes
In the letter cancellation test, which is part of behavioural inattention test (BIT) (Halligan et al., 1991) patients are seated at a table and asked to allocate a target on a sheet of paper placed on a table in front of them and cross it out from a background of different letters. It consists of 34 upper case letters and 40 targets evenly distributed on both sides of the page. The maximum score is 40 and the total number of target letters omitted is calculated and their location is determined (Plummer et al., 2003).
Catherine Bergego Scale
Time frame: 30 minutes
The CBS (Azouvi,1996), which involves a 10-item checklist used by the therapist or by the carer to observe and evaluate the presence as well as the severity of UN in the personal, peri-personal, and extra-personal space, will also be used in this study. It requires a 30-minute direct observation of the stroke survivor in 10 everyday activities like grooming or shaving the left part of the face, eating food on a plate, mouth cleaning, gaze orientation and knowledge of left sided parts of the body. UN is scored on a 4-point scale: mild (1), moderate (2), severe (3), or absent (0). A total score ranging from 0 to 30 is obtained with 0 = no behavioural neglect, 1-10 = mild behavioural neglect, 11-20 = moderate behavioural neglect, 21-30 = severe behavioural neglect.
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 15 May 2026.
- BackgroundRobertson H, Hogg K, McMillan M. (1998) Rehabilitation of unilateral neglect: improving function by contralesional limb activation. Neuropsychological Rehabilitation, 8(1): 19-29.
- Background: PubMed 12147008Bailey MJ, Riddoch MJ, Crome P. Treatment of visual neglect in elderly patients with stroke: a single-subject series using either a scanning and cueing strategy or a left-limb activation strategy. Phys Ther. 2002 Aug;82(8):782-97.
- Background: PubMed 23201425Winter JM, Crome P, Sim J, Hunter SM. Effects of mobilization and tactile stimulation on chronic upper-limb sensorimotor dysfunction after stroke. Arch Phys Med Rehabil. 2013 Apr;94(4):693-702. doi: 10.1016/j.apmr.2012.11.028. Epub 2012 Nov 28.
- Background: PubMed 34899565Williams LJ, Kernot J, Hillier SL, Loetscher T. Spatial Neglect Subtypes, Definitions and Assessment Tools: A Scoping Review. Front Neurol. 2021 Nov 24;12:742365. doi: 10.3389/fneur.2021.742365. eCollection 2021.
- BackgroundSim, J, Wright CH. (2000) Research in Health Care: Concepts, Designs and Methods. Cheltenham: Stanley Thornes.
- Background: PubMed 21282528Hunter SM, Hammett L, Ball S, Smith N, Anderson C, Clark A, Tallis R, Rudd A, Pomeroy VM. Dose-response study of mobilisation and tactile stimulation therapy for the upper extremity early after stroke: a phase I trial. Neurorehabil Neural Repair. 2011 May;25(4):314-22. doi: 10.1177/1545968310390223. Epub 2011 Jan 31.
- BackgroundHunter SM, Crome P, Sim J, Donaldson C, Pomeroy VM. (2006) Development of treatment schedules for research: a structured review to identify methodologies used and a worked example of 'mobilisation and tactile stimulation' for stroke patients. Clinical Rehabilitation, 92(4): 195-207.
- BackgroundBarlow D, Hersen M. (1984) Single case experimental designs: strategies for studying behavior change. Second Edition. New York: Pergamon Press.
- Individual participant dataSharing planned: No. The complete identifiable dataset will not be made publicly accessible in order to meet GDPR requirements, protect confidentiality, and comply with institutional policies. Instead, anonymised or aggregated data may be shared through publications, conference presentations, or research repositories.
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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.
Maryam H Mohammad contact
Ali Aries, PhD study chair
Keele University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobilization and Tactile Stimulation (MTS) in people with Stroke and Unilateral Neglect Syndrome, run by Keele University at 1 site in United Kingdom.
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 4 inclusion and 2 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 15 May 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 United Kingdom. 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 Ali Aries, PhD (07713278910, a.m.aries@keele.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fluff Test (time frame: 10 minutes). The study lists 3 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 NCT07589855, which also lists 8 linked publications.
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 15 May 2026.