Somatosensory Stimulation for Unilateral Neglect Post Stroke (SSUN)

NCT07589855 | Recruiting DMC

• 1 other identifier: RG-0405-25
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke; Unilateral Neglect Syndrome

Keywords

Stroke; Unilateral neglect; inattention; somatosensory stimulation; sensory stimulation; Mobilization and Tactile Stimulation

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  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.

  30 minutes

Study Arms (1)

MTS intervention

EXPERIMENTAL

Mobilization and Tactile stimulation (MTS) delivered 5x a week for 45min each time for 6 weeks

Other: Mobilization and Tactile Stimulation (MTS)

Interventions

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).

MTS intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Able and willing to receive and engage with regular therapy (MTS) (e.g. at home).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Keele University: lead
• National Health Service, United Kingdom: collaborator

Study Sites (1)

Midlands Partnership University NHS Foundation Trust

Newcastle-under-Lyme, ST55 7NJ, United Kingdom

RECRUITING

Related Publications (8)

• Robertson H, Hogg K, McMillan M. (1998) Rehabilitation of unilateral neglect: improving function by contralesional limb activation. Neuropsychological Rehabilitation, 8(1): 19-29.

  BACKGROUND

• 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.

  PMID: 12147008 BACKGROUND

• Winter 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.

  PMID: 23201425 BACKGROUND

• Williams 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.

  PMID: 34899565 BACKGROUND

• Sim, J, Wright CH. (2000) Research in Health Care: Concepts, Designs and Methods. Cheltenham: Stanley Thornes.

  BACKGROUND

• 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.

  PMID: 21282528 BACKGROUND

• Hunter 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.

  BACKGROUND

• Barlow D, Hersen M. (1984) Single case experimental designs: strategies for studying behavior change. Second Edition. New York: Pergamon Press.

  BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ali Aries, PhD

  Keele University

  STUDY CHAIR

Central Study Contacts

Ali Aries, PhD

CONTACT

07713278910; a.m.aries@keele.ac.uk

Maryam H Mohammad

CONTACT

m.h.mohammad@keele.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 15, 2026
• Study Start: October 20, 2025
• Primary Completion: July 1, 2026
• Study Completion: July 1, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)