Somatosensory Stimulation for Unilateral Neglect Post Stroke (SSUN) (SSUN)

May 13, 2026 updated by: Keele University

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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:

  1. Acceptability of the intervention: dose/frequency/comfort.
  2. Acceptability of the therapist coming to their home daily.
  3. Challenges/ barriers to completion they faced during the research study.
  4. Changes observed (perceived benefits).

Topics of discussion with the carers in an interview will include:

  1. Acceptability of carer-collected outcome measures: daily collection/ training
  2. Challenges/ barriers experienced in outcome measure's daily collection
  3. Acceptability of the frequency of MTS.
  4. 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 Type

Interventional

Enrollment (Estimated)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MTS intervention
Mobilization and Tactile stimulation (MTS) delivered 5x a week for 45min each time for 6 weeks
Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 minutes
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).
5 minutes
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.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keele University

Collaborators

National Health Service, United Kingdom

Investigators

  • Study Chair: Ali Aries, PhD, Keele University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

April 27, 2026

First Submitted That Met QC Criteria

May 13, 2026

First Posted (Actual)

May 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG-0405-25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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