Somatosensory Stimulation for Unilateral Neglect Post Stroke (SSUN)

Официальное название

Mobilization and Tactile Stimulation (MTS) to Improve Unilateral Neglect Post Stroke: a Pilot and Feasibility Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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

Первичные конечные точки

• Fluff Test [Срок оценки: 10 minutes]
• letter cancelation test [Срок оценки: 5 minutes]
• Catherine Bergego Scale [Срок оценки: 30 minutes]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Великобритания · 1 центр

• Midlands Partnership University NHS Foundation Trust — Newcastle-under-Lyme

Публикации

• 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. PMID 12147008
• 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
• 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
• Sim, 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. PMID 21282528
• 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.
• Barlow D, Hersen M. (1984) Single case experimental designs: strategies for studying behavior change. Second Edition. New York: Pergamon Press.

Идентификаторы

NCT: NCT07589855 · RG-0405-25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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