ISRCTN14710183RecruitingNot Applicable
Power Assisted Circuit Exercise for Stroke (PACE4S): A Refinement Study
Sheffield Teaching Hospitals NHS Foundation Trust0 sites30 target enrollmentStarted: June 1, 2026Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- N/a: Single Arm Study
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 110 Years (—)
- Sex
- All
Inclusion Criteria
- •Community dwelling adult aged 18 years or older (The study will not be delivered to people receiving in-patient rehabilitation)
- •Confirmed diagnosis of stroke; haemorrhagic or ischaemic (People with recurrent strokes will be eligible for recruitment)
- •Modified Rankin Scale score of 3 or 4 (We aim to target people living with some mobility impairment and/or dependence in activities of daily living. This will ensure that people typically excluded from previous exercise trials for stroke will have the opportunity to participate. The criteria developed by [London and Karmal 2025] will be implemented during the screening process to determine Modified Rankin Scale score)
- •Able to comprehend purpose of the study and provide informed consent (During the screening telephone call or home visit the Chief Investigator who is a Chartered Physiotherapist with expertise in stroke rehabilitation, will consider whether the potential participant has comprehended the purpose of the study and the commitment associated with participation. We do not plan to conduct quantified tests of mental capacity (e.g. Mini Mental Test) as this would not represent real world practice)
Exclusion Criteria
- •Contraindication to exercise according to American College of Sport’s Medicine (The screening telephone call or home visit will include questions about past medical history,current investigations,active treatments and prescribed medication. Wherever there is a concern about safety to engage in exercise due to a co-existing medical condition(s) recruitment to the study will be deferred and a medical review from either the GP or Co-Investigator,Dr Ali Ali (stroke consultant) will be requested)
- •The baseline assessment will include a submaximal exercise test with a target intensity of 85% age-predicted maximum heart rate (adjusted for beta-blockers). Heart rate,observed exertion and reported exertion will be monitored throughout the test. Blood pressure and oxygen saturation will be checked prior to and immediately after testing. Any abnormal responses to exercise will trigger medical review and deferred recruitment to the study.
- •Body weight greater than 150KG (The PACE equipment is CE Certified to support people weighing up to 150 KG. Weight will be checked during the baseline assessment. Any person weighing more than 150KG will be supported in accessing alternative physical activity options and nutritional advice)
- •Functional Ambulation Category less than 1 (People who are dependent on hoists or transfer aids to move between seated surfaces will not be eligible to join the study due to risk of injury to themselves or the research assistants)
- •Unable to follow verbal or non-verbal prompts or instructions (The ability to follow single-stage instructions which will be conveyed through a combination of verbal and non-verbal prompts with support from translators or carers as required will be assessed during the baseline assessment)
Investigators
Similar Trials
Not yet recruiting
Not Applicable
Combined effects of Mirror Therapy and Functional Electrical Stimulation on Hand Dexterity and Quality of Life in Stroke Survivors: A Clinical Randomized TrailCTRI/2024/08/072700Akansha Sarode60
Unknown
Not Applicable
经颅直流电刺激同步作业治疗对亚急性脑卒中患者上肢功能及脑电功率的影响ChiCTR2400082749徐州市医学重点人才项目(No.XWRCHT20220045)
Unknown
Not Applicable
60%AOP 下血流限制联合低强度抗阻运动对脑卒中患者下肢功能及神经电生理影响ChiCTR2100044004自筹100
Not yet recruiting
Not Applicable
tACS and Upper Limb Rehabilitation in Chronic StrokeStrokeNCT07778342National University Hospital, Singapore34
Recruiting
Unknown
经颅交流电刺激对脑卒中后执行功能障碍作用的临床研究脑卒中后执行功能障碍ChiCTR2600121506基于多模态评估方法的经颅交流电刺激治疗卒中后认知障碍的临床研究52