Somatosensory Stimulation for Unilateral Neglect Post Stroke (SSUN)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKeele University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Mobilization and Tactile Stimulation (MTS)
Other interventionMobilisation 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).
Treatment groups
6 Participants
are divided into 1 treatment groupGroup A: MTS interventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
10 minutes2
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).
Time frame
5 minutes3
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.
Time frame
30 minutesSponsors and contacts
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Keele University
Lead sponsor
National Health Service, United Kingdom
Collaborator
Source ClinicalTrials.gov