- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07623018
The Feasibility and Acceptability of a Gait Training Program Based on Telerehabilitation After Stroke
What is the Feasibility and Patient Acceptability of a Gait Training Program Based on Telerehabilitation After Stroke? A Mixed-methods, Single-arm Feasibility Study of the (STEP-Tech) Intervention
Přehled studie
Detailní popis
Stroke is the primary cause of disability and the second cause of death worldwide. In Saudi Arabia, the annual incidence rate is 57.64 per 100,000 people. Stroke-related disabilities may include cognitive dysfunction, sensory deficiencies, and motor difficulties. These impairments can result in weakened postural control, leading to imbalance and gait abnormalities.
Stroke survivors exhibit a slower gait cycle, reduced gait speed, a shorter stance phase, and a longer swing phase on the affected side, as well as differences in step lengths between the affected and unaffected sides. These gait characteristics limit functional movement abilities. Impaired walking abilities in patients with stroke represent a significant barrier to performing daily activities independently. Further, walking problems have been shown to reduce quality of life and limit participation, which, if untreated, leads to social isolation because walking is crucial for functional tasks.
Restoring walking capacity is a key objective of rehabilitation following a stroke, as stroke survivors primarily aim to increase walking safety and speed to prevent falls and enhance their quality of life. Therefore, intensive rehabilitation following a stroke is an essential component of patient care. Most people require rehabilitation after a stroke, which is often provided by medical professionals in hospital or clinic settings to improve patients' functional activities and quality of life. However, the lack of resources in facilities and rising medical costs make rehabilitation difficult, burdening both patients and healthcare policy services that aim for the best possible stroke recovery.
Compared to facility-based services, home-based telerehabilitation may encourage patients to improve their home environment and increase the frequency and intensity of their therapy. It is practical and can be used either as a supplement to or an alternative to traditional treatment, significantly enhancing therapeutic outcomes. Stroke telerehabilitation uses a variety of devices and software and can be delivered asynchronously, synchronously, or through a hybrid approach. Based on the findings from the umbrella review, a total of 28 systematic reviews were included that examined various telerehabilitation interventions after stroke. Simple and complex telerehabilitation interventions such as telephone calls, videoconferencing, smartphone or tablet-based mobile health applications, messaging, virtual and augmented reality, gaming, robot-assisted devices, 3D animation videos, and technology-assisted self-rehabilitation, either as standalone interventions or in combination with others, were included across reviews. These interventions have shown either a significant effect or no significant difference compared to other interventions in improving upper and lower limb motor function, balance, gait, ADLs and quality of life. A recent review found that exercise-based telerehabilitation is a feasible and potentially effective alternative to traditional post-stroke therapy. Improvements were observed in motor function, mobility, balance, and quality of life, while patient satisfaction and adherence remained high.
However, contextual dimensions, such as cultural, physical, social, spatial, organisational, political, or economic features of healthcare and the health system, impact the effectiveness and implementation of complex interventions. A qualitative study (currently under review), involving in-depth interviews with six patients with stroke, six carers, and ten physiotherapists, was conducted to gain deeper insight into their experiences and expectations regarding the implementation of telerehabilitation interventions after stroke in clinical practice in Saudi Arabia. The findings highlighted self-efficacy and motivation, which are influenced by cultural factors and barriers such as digital inequity, low awareness, inadequate training, cultural norms, and a preference for in-person care, all of which affect the adoption of telerehabilitation for patients with stroke in Saudi Arabia. However, telerehabilitation may support continuity of rehabilitation through appropriate training, family involvement, culturally sensitive approaches, and hybrid models.
The findings obtained from qualitative interviews were mapped onto the Behaviour Change Wheel (BCW) and the Theoretical Domains Framework (TDF) to develop a gait training program based on telerehabilitation intervention, Stroke Telerehabilitation for Enhanced Performance in Gait via Technology (STEP-Tech) intervention, as a promising solution to enhance gait quality, adherence and engagement to exercises at home, addressing all identified Behaviour Change Techniques (BCTs). The physiotherapist will deliver the intervention in a hybrid model; in two phases: phase one in the clinic, and phase two home-based. The development of this intervention has followed the UK Medical Research Council (MRC) framework for developing and evaluating complex interventions. The assessment of the feasibility of the intervention and evaluation design is the second phase of this framework, which involves assessing predefined progression criteria that relate to the evaluation design or the intervention itself.
Therefore, the overall aim of this study is to assess the feasibility and acceptability of delivering the STEP-Tech intervention to patients with stroke in the SA healthcare system and to evaluate the feasibility of conducting a future clinical trial to assess the programme's effectiveness.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Bayan Alwadai, PhD researcher
- Telefonní číslo: 07432573265
- E-mail: ba447@exeter.ac.uk
Studijní záloha kontaktů
- Jméno: Helen Dawes, Professor
- Telefonní číslo: 07934675772
- E-mail: H.Dawes@exeter.ac.uk
Studijní místa
-
-
-
Riyadh, Saudská arábie
- Sultan Bin Abdulaziz Humanitarian City (SBAHC)
-
Kontakt:
- Dr. Khalid Al Rubeaan, PhD
- Telefonní číslo: 00966115620000
- E-mail: research@sbahc.org.sa
-
Dílčí vyšetřovatel:
- Manal Alessa, Bachelor
-
-
Southern Region
-
Abhā, Southern Region, Saudská arábie
- Aseer Rehabilitation Centre
-
Kontakt:
- Dr Yahya Alogaibi, PhD
- Telefonní číslo: +966172251155
- E-mail: Rec-aseer@moh.gov.sa
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
For stage one of the study:
- People with stroke aged > 18 years living in Saudi Arabia.
- Diagnosed with ischemic or haemorrhagic stroke.
- People with stroke in the late-subacute or chronic phase ( ≥ 3 months after stroke onset).
- Patients can walk indoors for at least 10 meters with supervision and/or an assistive device (cane or walker).
- Patient with low fall risk (less than 20 seconds) based on the Timed Up and Go test (TUG).
- Ability to understand instructions and follow simple commands to participate in the study and give consent. Patients are required to obtain a score of seven or eight on the eight decisional capacity questionnaires that are relevant to the consent form content. These requirements are necessary to make sure that people can give consent. The decisional capacity questionnaire's content is based on the previously utilised University of California Brief Assessment Capacity to Consent (UBACC) questions that have been adjusted for the study's context.
- They are not currently participating in any other stroke rehabilitation study.
- Only those who can speak Arabic or English.
For stage 2 of the study (qualitative evaluation):
- Physiotherapists with experience working with people who have had a stroke (at least 2 years of experience).
- Carers aged 18 years or older who support patients during the intervention period
- Able to communicate in Arabic or English
Exclusion Criteria:
For stage one of the study :
- Patient with severe spasticity and contracture in the lower extremity (Modified Ashworth Scale 3 or 4).
- Unable to understand instructions to participate in the study and to give consent (due to severe cognitive impairments).
- Severe communication deficit or complete aphasia.
- Patients have another neurological condition (e.g., multiple sclerosis or Parkinson's disease) or a pre-stroke health condition that includes a gait disorder.
- Serious medical comorbidities such as pulmonary and heart disease, and uncontrolled hypertension.
For stage 2 of the study (qualitative evaluation):
- Physiotherapists with insufficient experience (less than 2 years' experience) in stroke rehabilitation.
- Carers who are unable to communicate well or have communication difficulties.
- Carers who are unable to give consent.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Participant group
The experimental group will receive STEP-Tech intervention to enhance gait quality, adherence and engagement to exercises at home, addressing all identified Behaviour Change Techniques (BCTs).
|
Stroke telerehabilitation for Enhanced Performance in Gait via technology (STEP-Tech) intervention was developed by the research team, using the UK Medical Research Council (MRC) framework for developing and evaluating complex interventions. The STEP-Tech intervention has 4 components: 1) Gait training using the Heel2Toe sensor. 2) A set of exercises that aim to enhance LL strengthening, stretching, balance and gait tasks. 3)Education. 4)Family and caregiver support. The STEP-Tech intervention will be delivered in a hybrid model in two phases. Phase 1 (preparatory phase): In-person in the outpatient department. Patients may require approximately three sessions with a physiotherapist over one week. Phase 2 (Home-based): Patients with stroke will be instructed to practise walking with the Heel2Toe sensor for a minimum of 5 minutes, twice a day, for four weeks. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Podíl způsobilých účastníků z prověřovaných účastníků
Časové okno: Během procesu screeningu
|
Celkový počet účastníků, kteří projdou fází screeningu.
|
Během procesu screeningu
|
|
Proportion of ineligible participants out of screened participants
Časové okno: During the screening process
|
The total number of participants who are ineligible and their reasons
|
During the screening process
|
|
Number of participants enrolled
Časové okno: During the enrolment process
|
Number of participants enrolled
|
During the enrolment process
|
|
Retention rate
Časové okno: Recorded at week 6
|
Retention rate is defined as the proportion of people who finished the intervention program after 5 weeks.
Retention rate will be assessed based on A) the number of participants who discontinued and the reasons.
B) proportion of participants with complete outcome assessment.
Data will be collected by using a screening log.
|
Recorded at week 6
|
|
Safety of intervention (any adverse events recorded)
Časové okno: During intervention period (5 weeks)
|
Adverse events are any unfavourable experiences that participants describe during the study, regardless of whether they were related to the intervention.
Participants will be asked to report any adverse effects to their physiotherapist during the weekly follow-up sessions.
|
During intervention period (5 weeks)
|
|
Fidelity of intervention delivery
Časové okno: During intervention period (5 weeks)
|
Physiotherapists will receive face-to-face training sessions on intervention delivery to ensure they have sufficient knowledge and skills to provide interventions to patients after stroke. To further enhance their skills, the P.I. will observe the first intervention session they deliver with every patient in the clinic and complete a checklist covering all intervention components to confirm fidelity. Patients' understanding of how to undertake the key intervention component at home will be checked by a physiotherapist during face-to-face sessions in the first week (phase 1) using a checklist for each participant. |
During intervention period (5 weeks)
|
|
Adherence rate
Časové okno: During intervention period (5 weeks)
|
Patients' adherence during phase 1(adherence to attend the face-to-face sessions in the clinic) will be evaluate through the attendance form.
Exercise adherence will be assessed through self-completed exercise logs and documentation obtained from a weekly follow-up session.
|
During intervention period (5 weeks)
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
6-Minute Walk Test (6MWT)
Časové okno: at baseline (pre-intervention) and immediately after the intervention (at week 6).
|
The six-minute walk test measures the distance that a person can walk in six minutes.
For individuals with stroke, the six-minute walk test is a validated and recommended rehabilitation outcome measure of aerobic and walking capacity.
The score is the distance the patient walks in 6 minutes.
Generally, for healthy adults without mobility problems, the typical score is between 1,311 and 2,295 feet.
Higher scores indicate better endurance and exercise tolerance.
|
at baseline (pre-intervention) and immediately after the intervention (at week 6).
|
|
Five-Times-Sit-To-Stand Test (FTSTS)
Časové okno: at baseline (pre-intervention) and immediately after the intervention (at week 6)
|
The FTSTS measures the time it takes a stroke patient to perform five sit-to-stand repetitions to assess lower-limb muscle strength and balance.
The test requires the participant to sit in a chair with their back against the backrest and their arms folded across their chest.
Therefore, it is recommended that the chair be 43-46 cm in height and have a straight back.
When instructed, the participant should perform the exercise as quickly as possible by standing up fully and then sitting down for five repetitions.
The FTSST is a practical, reliable, and affordable tool for evaluating the ability to stand and sit within a short period of time.
|
at baseline (pre-intervention) and immediately after the intervention (at week 6)
|
|
Rivermead Mobility Index
Časové okno: at baseline (pre-intervention) and immediately after the intervention (at week 6).
|
There are 15 items on the Rivermead Mobility Index, including 1 direct observation and 14 self-reported items.
Items receive a score of 1 if the patient successfully completes the task, or 0 if they are unable to do so.
A maximum score of 15 is then obtained by adding the points; higher scores indicate greater functional mobility.
|
at baseline (pre-intervention) and immediately after the intervention (at week 6).
|
|
The indicator of gait quality (The number of recorded steps)
Časové okno: at baseline (pre-intervention) and immediately after the intervention (at week 6).
|
The number of recorded steps obtained from the Heel2Toe sensor during the 6-Minute Walk Test (6MWT).
Unit: steps
|
at baseline (pre-intervention) and immediately after the intervention (at week 6).
|
|
The indicator of gait quality (Number of good steps)
Časové okno: at baseline (pre-intervention) and immediately after the intervention (at week 6)
|
the number of good steps obtained from the Heel2Toe sensor during the 6-minute walk test (6MWT).
Unit: steps
|
at baseline (pre-intervention) and immediately after the intervention (at week 6)
|
|
The indicator of gait quality: Angular velocity at heel strike
Časové okno: at baseline (pre-intervention) and immediately after the intervention (at week 6)
|
The speed at which the foot moves from dorsiflexion when the heel strikes the ground to neutral when the foot is flat on the floor.
Unit: °/sec.
Rating: Excellent (Maximum): -400 to < -320, Very Good: -320 to < -280, Good: -280 to < -200, Fair: -200 to < -120; and Poor (Minimum): < -120.
|
at baseline (pre-intervention) and immediately after the intervention (at week 6)
|
|
The indicator of gait quality: Angular velocity at push- off
Časové okno: at baseline (pre-intervention) and immediately after the intervention (at week 6)
|
The speed at which the heel lifts off the floor to propel the body forward.
It is recorded as a negative value by the sensor.
Unit: °/sec.
Rating: Excellent (Maximum): -600 to -481, Very good: -480 to -421, Good: -420 to -301, Fair: -300 to -121, and Poor (Minimum): -120 to 0
|
at baseline (pre-intervention) and immediately after the intervention (at week 6)
|
|
The indicator of gait quality: Angular velocity at foot clearance
Časové okno: at baseline (pre-intervention) and immediately after the intervention (at week 6)
|
The speed at which the foot pivots around the ankle joint from plantarflexion at push-off to dorsi-flexion when the leg is preparing to position the foot to make a heel strike.
The value is positive.
Unit: °/sec.
Rating: Excellent (Maximum): 600, Very good: 400, Good: 360, Fair: 340, and Poor (Minimum): 200
|
at baseline (pre-intervention) and immediately after the intervention (at week 6)
|
|
The indicator of gait quality: Angular velocity at Power phase
Časové okno: at baseline (pre-intervention) and immediately after the intervention (at week 6)
|
The phase of the gait cycle from heel strike to push off that essentially generates the power to propel the body forward.
It is recorded as a negative value and is measured in (°/sec)2.
Rating: Excellent (Maximum): - 4500, Very good: -4000, Good: -3500, Fair: -3000 and Poor (Minimum): -2000
|
at baseline (pre-intervention) and immediately after the intervention (at week 6)
|
|
The indicator of gait quality: Angular velocity at Balance Phase
Časové okno: at baseline (pre-intervention) and immediately after the intervention (at week 6)
|
The swing phase of the gait cycle when one foot is in the air swinging forward and the other foot is on the ground.
The height and duration of the swing creates an area measured in (°/sec).
Rating: Excellent (Maximum): >4000, Very good: 3601-4000, Good: 3201 to 3600, Fair: 2500 to 3200 and Poor (Minimum): < 2500
|
at baseline (pre-intervention) and immediately after the intervention (at week 6)
|
|
The indicator of gait quality: coefficients of variation (CV) of angular velocity (AV): heel strike
Časové okno: at baseline (pre-intervention) and immediately after the intervention (at week 6)
|
The coefficient of variation is the ratio of the standard deviation of AV to the average value, indicating how consistently a person walks.
It will be obtained from the Heel2Toe sensor during the 6MWT.
Rating: Excellent (Maximum): 10 to <20, Very Good: 20 to < 25, Good: 25 to < 30, Fair: 30 to < 50 and Poor (Minimum): ≥50
|
at baseline (pre-intervention) and immediately after the intervention (at week 6)
|
|
The indicator of gait quality: coefficients of variation (CV) of angular velocity (AV): Push-off
Časové okno: at baseline (pre-intervention) and immediately after the intervention (at week 6)
|
The coefficient of variation is the ratio of the standard deviation of AV to the average value, indicating how consistently a person walks.
It will be obtained from the Heel2Toe sensor during the 6MWT.
Rating: Excellent (Maximum): 5 to <15, Very Good: 15 to < 25, Good: 25 to < 30, Fair: 30 to < 50 and Poor (Minimum): ≥50
|
at baseline (pre-intervention) and immediately after the intervention (at week 6)
|
|
The indicator of gait quality: coefficients of variation (CV) of angular velocity (AV): Foot clearance
Časové okno: at baseline (pre-intervention) and immediately after the intervention (at week 6)
|
The coefficient of variation is the ratio of the standard deviation of angular velocity to the average value, indicating how consistently a person walks.
Rating: Excellent (Maximum): 5 to <10, Very Good: 10 to < 15, Good: 15 to < 20, Fair: 20 to < 30 and Poor (Minimum): ≥ 30
|
at baseline (pre-intervention) and immediately after the intervention (at week 6)
|
|
The indicator of gait quality: coefficients of variation (CV) of of angular velocity (AV): Power Phase
Časové okno: at baseline (pre-intervention) and immediately after the intervention (at week 6)
|
The coefficient of variation is the ratio of the standard deviation of angular velocity to the average value, indicating how consistently a person walks.
Rating: Excellent (Maximum): 8, Very Good: 9-15 , Good: 16-20, Fair: 21-30 and Poor (Minimum): 31-50
|
at baseline (pre-intervention) and immediately after the intervention (at week 6)
|
|
The indicator of gait quality: coefficients of variation (CV) of angular velocity (AV): Balance Phase
Časové okno: at baseline (pre-intervention) and immediately after the intervention (at week 6)
|
The coefficient of variation is the ratio of the standard deviation of angular velocity to the average value, indicating how consistently a person walks.
Rating: Excellent (Maximum): 10 to < 15, Very Good: 15 to < 20, Good: 20 to < 30 , Fair: 30 to < 50 and Poor (Minimum): 50
|
at baseline (pre-intervention) and immediately after the intervention (at week 6)
|
|
Health-related quality of Life: Euro-Quality of Life-5 Dimension-5 Level Scale (EQ-5D-5L)
Časové okno: will be assessed at baseline (pre-intervention) and immediately after the intervention (at week 6).
|
The Euro-Quality of Life-5 Dimension-5 Level Scale(EQ-5D-5L) is a valid and useful instrument for assessing the quality of life (QoL) in both research and clinical practice for people with stroke.
(EQ-5D-5L) has five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, scored by level of severity for each dimension (1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems and 5= extreme problems).
Overall health status is also measured using a visual analogue score out of 100 whereby higher scores = better quality of life.
|
will be assessed at baseline (pre-intervention) and immediately after the intervention (at week 6).
|
|
The acceptability outcome
Časové okno: Completed after week 6
|
Following completion of the intervention, participants-including patients with stroke and their carers who completed the full intervention period, those who dropped out during the study, and the physiotherapists who delivered the intervention-will be invited to take part in a semi-structured interview.
Interviews will be conducted either face-to-face at the hospital or online via Microsoft Teams by the Principal Investigator (PI) to explore participants' opinions and experiences, as well as perceived barriers and facilitators to using the intervention
|
Completed after week 6
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 10444866
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na STEP-Tech intervention
-
University of California, San FranciscoNorthern California Institute of Research and Education; San Francisco Veterans... a další spolupracovníciDokončenoOdvykání kouřeníSpojené státy
-
Azienda Ospedaliera Città della Salute e della...Dokončeno
-
Florida International UniversityThe Children's Trust, Miami FLDokončenoExternalizující chováníSpojené státy
-
State University of New York at BuffaloUkončenoDiabetes mellitus, typ 2Spojené státy
-
University of Alabama at BirminghamDokončenoCukrovka typu 2 | Tělesné postiženíSpojené státy
-
Ohio State UniversityDokončenoAmbulantní | Vztahy lékař-pacient | Diagnostika lůžkových zařízení | Elektronické zdravotní záznamySpojené státy
-
Johns Hopkins UniversityNational Institute of Nursing Research (NINR)Aktivní, ne náborZánětlivé onemocnění pánveSpojené státy
-
Sohag UniversityZatím nenabíráme
-
Medical University of GrazDokončeno
-
University of PittsburghPatient-Centered Outcomes Research Institute; The Cleveland Clinic; Mount Sinai...DokončenoSymptomy chování | Zánětlivé onemocnění střevSpojené státy