Clinical trial NCT05158543: Intensity Dependent Effects of 'FAST-Table' on Physical Performance in Stroke
Official title: Intensity-dependent Effects of 'Functional Activities Specific Training-Table' on Physical Performance in Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: According to the World Health Organization (WHO), stroke is defined as "rapidly developing clinical signs of focal (or global) disturbance of cerebral function, with symptoms lasting 24 hours or longer or leading to death, with no apparent cause other than of vascular origin". By applying this definition, transient ischemic attack (TIA), which is defined to last less than 24 hours, and patients with stroke symptoms caused by subdural hemorrhage, tumors, poisoning, or trauma, are excluded.Task-oriented training (TOT) involves active training of motor tasks performed within a clear functional context that includes complex whole task or pre-task movements of the whole limb or a limb segment. A high number of repetitions performed within a single session characterizes this training. According to the literature, TOT results in neuroplastic changes and is critical for improving motor and functional recovery. Task-specific training is based fundamentally on the concept that repeated practice results in learning a specific task. There is increasing evidence of neural plastic changes associated with repeated training, and several aspects of rehabilitation entail repetition of movement. Repeated motor practice has been demonstrated to decrease muscle weakness and spasticity and form the physiological foundation of motor learning. Repeated practice of challenging movement tasks results in larger brain representations of the practiced movement.

Detailed description: The effectiveness of a high-intensity task-oriented training (TOT) program seems related to higher intensity of practice and cardiorespiratory workload. Implementing a high number of repetitions and a high cardiorespiratory workload showed improvement in hemiparetic gait with feasibility and exceeds the effectiveness of a low-intensity physiotherapy program to walk capacity and walking speed. The Canadian Best Practice guidelines for rehabilitation recommend that patients should receive a minimum of three hours of task-oriented training, five days per week. However, Lee et al. stated that adhering to the repeated practices for a long duration of time often poses challenges to both stroke survivors and healthcare providers. Similarly, it is possible that within three hours one can do a few repetitions of TOT with long breaks in between and therefore, end up doing an inadequate number of repetitions than the number that may be required to attain the desired goal. It is possible within an hour to perform a large amount of TOT that would have undesired adverse effects such as fatigue and pain, which may subsequently affect recovery. The number of repetitions in a session of TOT, and the frequency of sessions per week that would promote motor learning in the upper extremity might differ from that of the lower extremity. Therefore, in administering TOT during stroke rehabilitation, the number of repetitions of TOT per treatment session may arguably be more useful than the number of hours covered while practicing. The effectiveness of the number of repetitions of TOT in a training session for stroke rehabilitation has been investigated in the literature; however, the studies were not in agreement on the number of repetitions of TOT per session required to produce the desired rehabilitation outcome for upper and lower extremities. Different studies have used varied numbers of repetitions per treatment session; however, the number of repetitions needed for optimal human learning without adverse effect is still contentious.

Previous literature has sufficient evidence about the effects of task-oriented training on the stroke population but there is limited evidence about the number of repetitions needed for optimal human learning without adverse effects is still unknown. Some studies compared the number of repetitions of tasks, some compared the number of sessions (single session/double session)/day or per week, some studies reported different duration per session, and some studies compared 3, 4, 6, 8 weeks duration. However, none of the studies have reported on all parameters of dosage at once. The current study aims to identify the effects of different dosages (standard, medium, and high intensity). Second, previous literature mainly focused on the repetition (reps) of a single task (mass practice), and limited functional tasks were available for practice, while the current study aims at providing more and more functional tasks with limited repetitions to maintain the interest level of patients for practice and allow for variability in task practice and to avoid the boredom that might come from performing ≥100 repetitions of a single task. Third, there is a variety of equipment available for stroke rehabilitation focusing on separate body domains, but no specific equipment focuses on complete stroke rehabilitation protocol. The current study aims to develop "Functional Activities Specific Training Table (FAST-Table), which will offer all functional tasks (whole-body rehabilitation protocol) on one table and this table will serve as an intervention and an assessment tool. Fourthly, previous literature has used a variety of tasks for stroke rehabilitation; the current study aims to develop 100 specific functional tasks for stroke to perform on FAST-table. 100 standard tasks for stroke, upper limb "30tasks\*10 repetition of each task= 300 reps",lower limb "30tasks\*10 repetition of each task= 300 reps",balance "30tasks\*10 repetition of each task= 300 rep", cognition "10tasks\*10 repetition of each task= 100 reps" and Total 1000 reps/session.

Eligibility criteria: Inclusion Criteria:

* Both Genders
* Age between 40-60 years.
* ≥3 months post stroke.
* Middle \& anterior Cerebral Artery stroke
* 18-25 points Mild cognitive impairment Montreal Cognitive Assessment (MoCA)
* FMA UE and LE collectively motor score 50-70
* Modified Rankin scale 3-4

Exclusion Criteria:

* Inability to follow 2-step commands
* Ashworth scale 3-4
* Current participation in other stroke treatments
* Other neurological diagnoses, history of fall \& fractures
* pregnancy

Primary outcomes:
measure: Fugl-Meyer Assessment (FMA)
timeFrame: week 12
measure: Wolf Motor Function Test
timeFrame: week 12
measure: Time up and go test
timeFrame: week 12
measure: Berg balance scale (BBS)
timeFrame: week 12
measure: Wisconsin gait scale
timeFrame: week 12
Secondary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: week 12
measure: Stroke- Specific Quality of life SS (QOL)
timeFrame: week 12
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Riphah International University
Study officials:
affiliation: Riphah International University
name: Arshad Nawaz Malik, PhD
role: PRINCIPAL_INVESTIGATOR
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