Intensity Dependent Effects of 'FAST-Table' on Physical Performance in Stroke
Primary Purpose
Stroke
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
conventional therapy
Task oriented training (moderate intensity)
Task oriented training (high intensity)
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- Both Genders
- Age between 40-60 years.
- ≥3 months post stroke.
- Middle Cerebral Artery stroke
- Montreal Cognitive Assessment (MoCA) ≥26
- Unilateral upper limb weakness, as indicated by a score of 1-3 on item 5 (arm motor drift item) on the NIHSS
- Mild-to-moderate functional motor capacity of the affected upper limb, as indicated by a score of 10-48 on the Action Research Arm Test (ARAT)
- Unilateral lower limb weakness, as shown by a score of 1-3 on item 6 (Leg motor drift item) on the NIHSS
- Modified Rankin scale 3-4
Exclusion Criteria:
- Inability to follow 2-step commands
- Cognitive impairments
- Ashworth scale 3-4
- Current participation in other stroke treatments
- Other neurological diagnoses, history of fall & fractures
- pregnancy
Sites / Locations
- Riphah International UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Control Group
moderate intensity group
high intensity group
Arm Description
the control group will receive conventional intervention for upper and lower limb motor function & balance.
this group will get task-oriented training with moderate intensity using Functional activities specific training-table (FAST-Table) with 100 functional tasks.
this group will get task-oriented training with high intensity using Functional activities specific training-table (FAST-Table) with 100 functional tasks.
Outcomes
Primary Outcome Measures
Fugl-Meyer Assessment (FMA)
Stroke-specific, performance-based impairment index. It assesses motor functioning, balance, sensation, and joint functioning in patients with post-stroke hemiplegia. The scale is comprised of five domains and there are 155 items in total: Motor functioning (in the upper and lower extremities), Sensory functioning (evaluates light touch on two surfaces of the arm and leg, and position sense for 8 joints), Balance (contains 7 tests, 3 seated and 4 standing), Joint range of motion (8 joints), Joint pain.
Wolf Motor Function Test
The Wolf Motor Function Test (WMFT) quantifies the motor function of the upper extremity (UE) through timed and functional tasks. The widely used version of the WMFT consists of 17 items. The first 6 items involve timed functional tasks, items 7 and 14 are measures of strength, and the remaining 9 items comprise analyzing movement quality when completing various tasks.
Time up and go test
The Timed Up and Go Test (TUG) is an objective clinical measure for assessing functional mobility and balance, and thus the risk of falling. The TUG measures the time taken for an individual to rise from a chair, walk 3 meters, turn, walk back and sit down.
Berg balance scale (BBS)
The Berg Balance Scale assesses the balance of patients with different neurological disorders. A subject's performance on each task is graded with a 5- point ordinal scale ranging from 0 to 4, with higher scores awarded because of speed, stability, or help required for completion of the task. It summed the task scores to give a total BBS score out of a possible 56 points with higher scores representing better balance.
Wisconsin gait scale
The Wisconsin Gait Scale (WGS) can be used to evaluate the gait problems experienced by a patient with hemiplegia following stroke. Interpretation:
minimum score: 13.35
maximum score: 42
The higher the score the more seriously affected the gait
Secondary Outcome Measures
Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment (MoCA) is a brief 30-question test that takes around 10 to 12 minutes to complete and helps assess people for dementia. A group published it in 2005 at McGill University, working for several years at memory clinics in Montreal.
Stroke- Specific Quality of life SS (QOL)
The Stroke Specific Quality Of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life (HRQOL) specific to patients with Stroke. Patients must respond to each question of the SS-QOL regarding the past week. It is a self-report scale containing 49 items in 12 domains: Mobility (6 items), Energy (3 items), Upper extremity function (5 items), Work/productivity (3 items), Mood (5 items), Self-care (5 items), Social roles (5 items), Family roles (3 items), Vision (3 items), Language (5 items), Thinking (3 items) and Personality (3 items).
Full Information
NCT ID
NCT05158543
First Posted
December 13, 2021
Last Updated
February 23, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05158543
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
the control group will receive conventional intervention for upper and lower limb motor function & balance.
Arm Title
moderate intensity group
Arm Type
Experimental
Arm Description
this group will get task-oriented training with moderate intensity using Functional activities specific training-table (FAST-Table) with 100 functional tasks.
Arm Title
high intensity group
Arm Type
Experimental
Arm Description
this group will get task-oriented training with high intensity using Functional activities specific training-table (FAST-Table) with 100 functional tasks.
Intervention Type
Other
Intervention Name(s)
conventional therapy
Intervention Description
The conventional group will receive active and passive range of motion exercises, balance, and strength training for upper and lower limbs. One session per day, three sessions/week for total of 12 weeks.
Intervention Type
Other
Intervention Name(s)
Task oriented training (moderate intensity)
Intervention Description
In the moderate-intensity group, patients will perform 100 functional tasks with a total (1000) repetitions. Single session/day, 4 sessions/week for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Task oriented training (high intensity)
Intervention Description
In the moderate-intensity group, patients will perform 100 functional tasks with a total (1000) repetitions. Two sessions/day, 5 sessions/week for 12 weeks.
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment (FMA)
Description
Stroke-specific, performance-based impairment index. It assesses motor functioning, balance, sensation, and joint functioning in patients with post-stroke hemiplegia. The scale is comprised of five domains and there are 155 items in total: Motor functioning (in the upper and lower extremities), Sensory functioning (evaluates light touch on two surfaces of the arm and leg, and position sense for 8 joints), Balance (contains 7 tests, 3 seated and 4 standing), Joint range of motion (8 joints), Joint pain.
Time Frame
week 12
Title
Wolf Motor Function Test
Description
The Wolf Motor Function Test (WMFT) quantifies the motor function of the upper extremity (UE) through timed and functional tasks. The widely used version of the WMFT consists of 17 items. The first 6 items involve timed functional tasks, items 7 and 14 are measures of strength, and the remaining 9 items comprise analyzing movement quality when completing various tasks.
Time Frame
week 12
Title
Time up and go test
Description
The Timed Up and Go Test (TUG) is an objective clinical measure for assessing functional mobility and balance, and thus the risk of falling. The TUG measures the time taken for an individual to rise from a chair, walk 3 meters, turn, walk back and sit down.
Time Frame
week 12
Title
Berg balance scale (BBS)
Description
The Berg Balance Scale assesses the balance of patients with different neurological disorders. A subject's performance on each task is graded with a 5- point ordinal scale ranging from 0 to 4, with higher scores awarded because of speed, stability, or help required for completion of the task. It summed the task scores to give a total BBS score out of a possible 56 points with higher scores representing better balance.
Time Frame
week 12
Title
Wisconsin gait scale
Description
The Wisconsin Gait Scale (WGS) can be used to evaluate the gait problems experienced by a patient with hemiplegia following stroke. Interpretation:
minimum score: 13.35
maximum score: 42
The higher the score the more seriously affected the gait
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Montreal Cognitive Assessment (MoCA)
Description
The Montreal Cognitive Assessment (MoCA) is a brief 30-question test that takes around 10 to 12 minutes to complete and helps assess people for dementia. A group published it in 2005 at McGill University, working for several years at memory clinics in Montreal.
Time Frame
week 12
Title
Stroke- Specific Quality of life SS (QOL)
Description
The Stroke Specific Quality Of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life (HRQOL) specific to patients with Stroke. Patients must respond to each question of the SS-QOL regarding the past week. It is a self-report scale containing 49 items in 12 domains: Mobility (6 items), Energy (3 items), Upper extremity function (5 items), Work/productivity (3 items), Mood (5 items), Self-care (5 items), Social roles (5 items), Family roles (3 items), Vision (3 items), Language (5 items), Thinking (3 items) and Personality (3 items).
Time Frame
week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arshad Nawaz Malik, PhD
Phone
03325962212
Email
arshad.nawaz@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arshad Nawaz Malik, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Rawalpindi
ZIP/Postal Code
64400
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayesha Afridi, MS NMPT
Email
afridi.ayesha@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Intensity Dependent Effects of 'FAST-Table' on Physical Performance in Stroke
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