Somatosensory Stimulation for Unilateral Neglect Post Stroke (SSUN)
NCT07589855 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2026-05-15
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
Interventions
- 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).
Sponsors & Collaborators
-
National Health Service, United Kingdom
collaborator OTHER_GOV -
Keele University
lead OTHER
Principal Investigators
-
Ali Aries, PhD · Keele University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-20
- Primary Completion
- 2026-07-01
- Completion
- 2026-07-01
Countries
- United Kingdom
Study Locations
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