Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563206
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-17
Brief Title:
Exergame and Robotic Therapy Impact on Tenascin-C and Functional Outcome on Stroke Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of Tenascin-C Value Rates and Functional Outcomes Between Exergame Therapy and Robotic Therapy in Post-Stroke Patients
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial aims to compare the effectiveness of Robotic versus Exergame versus Standard therapy to improve hand function among post-stroke patients The main questions it aims to answer are
1 Effectiveness of interventions in functional outcome recovery across time 2 Effectiveness of interventions in affecting Tenascin-C level 3 Clinical outcome difference between all interventions
Participants will be allocated into three groups either a robotic group exergame group as the main interventions and standard rehabilitation group as the active comparator A serial follow-up will be conducted to assess the selected clinical outcome and differences in outcome
1 Effectiveness of interventions in functional outcome recovery across time 2 Effectiveness of interventions in affecting Tenascin-C level 3 Clinical outcome difference between all interventions
Participants will be allocated into three groups either a robotic group exergame group as the main interventions and standard rehabilitation group as the active comparator A serial follow-up will be conducted to assess the selected clinical outcome and differences in outcome
Detailed Description:
1 Research design This research is an experimental study with a randomized controlled trial research design
2 Study Setting The research will be carried out among post-stroke patients at two teaching hospitals and one physical rehabilitation center in Makassar
3 Procedure
a Standard Rehabilitation Comprehensive medical management and rehabilitation of disabilities caused by stroke through the neurorehabilitation approach with the aim of optimizing recovery and or modifying existing remaining symptoms so that stroke people are able to carry out functional activities independently can adapt to the environment and achieve quality life
b Exergame Physical exercise of the entire body carried out through active video games that require gross motor skills visual-spatial coordination balance and energy expenditure that are proportional to the intensity of moderate physical activity
c Robotic Therapy Mirror therapy intervention uses the help of robot exoskeletal to move the sick side A set of mirror therapy exercises using Syrebo robotics using 1 set of Activity Daily Living ADL training during therapy and using a mirror that will reflect a healthy side shadow
4 Time frame the procedure will be conducted in parallel three times per week for a total of six weeks with two measurements before and after six weeks of training
5 Outcomes
1 motoric ability of upper extremity using Fugl-Meyer Assessment for Upper Extremities FMA-UE
2 Dexterity coordination and response of finger using the Nine Hole Peg Test NHPT
3 Hand motor strength with Handgrip dynamometer
4 Level of Tenascin-C in blood serum before and after
6 Case definition
a type of stroke determined by radiology imaging b phase of stroke acute sub-acute or chronic c cognitive ability measured using mini-mental state examination MMSE d Spasticity measured by the Modified Ashworth Scale MAS
7 Procedure
a The data collected is primary data obtained in accordance with the inclusion criteria
b Samples who are willing to become research subjects will undergo interviews physical examinations FMA-UE-Hand Motor Domain handgrip and NHPT examinations The interview questionnaire in this study will contain a list of patient identities including name age marital status address educational history employment history history of stroke cognitive examination MMSE and self-reported visual ability
8 Measurement tools
1 The FMA-UE-Hand Motor Domain scoring system is used to evaluate upper extremity motor function in patients with neurological disorders such as stroke The scoring system ranges from 0-14 with higher scores indicating better motor function The FMA-UE-Hand Motor domain assessment system is broken down into several subscales namely Mass Flexion and Extension movements followed by functional movements of grasping Grasp including Hook Grasp Thumb Adduction Pincer Grasp Cylinder Grasp and Spherical Grasp The assessment will get a score of 0 None or no movement 1 Partial or limited movement and 2 Full or perfect movement
2 The NHPT assessment consists of a square board with 9 pegs At one end of the board there is a hole for the peg and at the other end there is a shallow round plate for holding the peg NHPT is performed by having the patient take pegs from a container one at a time and place them into the holes in a board as quickly as possible The patient must then remove the pegs from the holes one at a time and reinsert them into the housing To practice and register initial scores the test must be started with the unaffected upper limb The board should be placed in the centre of the patients body with the housing holding the pegs oriented toward the hand being tested Only the hand being evaluated should perform the test The non-evaluated hand is allowed to grip the edge of the board to provide stability Patients are scored based on the time required to complete the test activity recorded in seconds The stopwatch must start from the moment the participant touches the first peg until the last peg touches the container This assessment requires a board of wood or plastic with 9 holes 10 mm diameter 15 mm depth spaced 32 mm or 50 mm apart and a stopwatch
3 Tenascin-C To perform an ELISA for Tenascin-C the procedure involves preparing samples and standards according to the kit instructions The samples and standards are added to wells pre-coated with Tenascin-C-specific antibodies and incubated to facilitate binding Following incubation the wells are washed to remove any unbound substances A detection antibody conjugated with an enzyme is then added and incubated After additional washing a substrate solution is introduced causing a color change proportional to the amount of Tenascin-C present The reaction is stopped with an acid solution and the optical density is measured using a plate reader The Tenascin-C concentration in the samples is determined by comparing the optical density readings to a standard curve Typically Tenascin-C levels are reported in pgmL and the assay range and sensitivity depend on the specific kit used Accurate interpretation requires comparing the sample values to the standard curve to assess Tenascin-C expression levels which can provide insights into the biological or pathological state being investigated
9 Sample Size
This clinical trial aims to compare the effectiveness of Robotic Therapy Exergame Therapy and Standard Therapy in improving hand function among post-stroke patients Assuming a standard deviation of 2675 an expected mean difference of 1872 and a dropout rate of 30 the sample size is calculated to be 16 participants per group This calculation is based on a 95 confidence level Zα 196 and 80 power Zβ 084 across the three arms
10 Proposed Statistical Analysis
the data will be analyzed using Analysis of Variance ANOVA assuming no difference in baseline characteristic Next the relationship between continuous values will be assessed using the Pearson correlation test normally distributed data or the Spearman test data not normally distributed to determine how big the correlation is between these variables
2 Study Setting The research will be carried out among post-stroke patients at two teaching hospitals and one physical rehabilitation center in Makassar
3 Procedure
a Standard Rehabilitation Comprehensive medical management and rehabilitation of disabilities caused by stroke through the neurorehabilitation approach with the aim of optimizing recovery and or modifying existing remaining symptoms so that stroke people are able to carry out functional activities independently can adapt to the environment and achieve quality life
b Exergame Physical exercise of the entire body carried out through active video games that require gross motor skills visual-spatial coordination balance and energy expenditure that are proportional to the intensity of moderate physical activity
c Robotic Therapy Mirror therapy intervention uses the help of robot exoskeletal to move the sick side A set of mirror therapy exercises using Syrebo robotics using 1 set of Activity Daily Living ADL training during therapy and using a mirror that will reflect a healthy side shadow
4 Time frame the procedure will be conducted in parallel three times per week for a total of six weeks with two measurements before and after six weeks of training
5 Outcomes
1 motoric ability of upper extremity using Fugl-Meyer Assessment for Upper Extremities FMA-UE
2 Dexterity coordination and response of finger using the Nine Hole Peg Test NHPT
3 Hand motor strength with Handgrip dynamometer
4 Level of Tenascin-C in blood serum before and after
6 Case definition
a type of stroke determined by radiology imaging b phase of stroke acute sub-acute or chronic c cognitive ability measured using mini-mental state examination MMSE d Spasticity measured by the Modified Ashworth Scale MAS
7 Procedure
a The data collected is primary data obtained in accordance with the inclusion criteria
b Samples who are willing to become research subjects will undergo interviews physical examinations FMA-UE-Hand Motor Domain handgrip and NHPT examinations The interview questionnaire in this study will contain a list of patient identities including name age marital status address educational history employment history history of stroke cognitive examination MMSE and self-reported visual ability
8 Measurement tools
1 The FMA-UE-Hand Motor Domain scoring system is used to evaluate upper extremity motor function in patients with neurological disorders such as stroke The scoring system ranges from 0-14 with higher scores indicating better motor function The FMA-UE-Hand Motor domain assessment system is broken down into several subscales namely Mass Flexion and Extension movements followed by functional movements of grasping Grasp including Hook Grasp Thumb Adduction Pincer Grasp Cylinder Grasp and Spherical Grasp The assessment will get a score of 0 None or no movement 1 Partial or limited movement and 2 Full or perfect movement
2 The NHPT assessment consists of a square board with 9 pegs At one end of the board there is a hole for the peg and at the other end there is a shallow round plate for holding the peg NHPT is performed by having the patient take pegs from a container one at a time and place them into the holes in a board as quickly as possible The patient must then remove the pegs from the holes one at a time and reinsert them into the housing To practice and register initial scores the test must be started with the unaffected upper limb The board should be placed in the centre of the patients body with the housing holding the pegs oriented toward the hand being tested Only the hand being evaluated should perform the test The non-evaluated hand is allowed to grip the edge of the board to provide stability Patients are scored based on the time required to complete the test activity recorded in seconds The stopwatch must start from the moment the participant touches the first peg until the last peg touches the container This assessment requires a board of wood or plastic with 9 holes 10 mm diameter 15 mm depth spaced 32 mm or 50 mm apart and a stopwatch
3 Tenascin-C To perform an ELISA for Tenascin-C the procedure involves preparing samples and standards according to the kit instructions The samples and standards are added to wells pre-coated with Tenascin-C-specific antibodies and incubated to facilitate binding Following incubation the wells are washed to remove any unbound substances A detection antibody conjugated with an enzyme is then added and incubated After additional washing a substrate solution is introduced causing a color change proportional to the amount of Tenascin-C present The reaction is stopped with an acid solution and the optical density is measured using a plate reader The Tenascin-C concentration in the samples is determined by comparing the optical density readings to a standard curve Typically Tenascin-C levels are reported in pgmL and the assay range and sensitivity depend on the specific kit used Accurate interpretation requires comparing the sample values to the standard curve to assess Tenascin-C expression levels which can provide insights into the biological or pathological state being investigated
9 Sample Size
This clinical trial aims to compare the effectiveness of Robotic Therapy Exergame Therapy and Standard Therapy in improving hand function among post-stroke patients Assuming a standard deviation of 2675 an expected mean difference of 1872 and a dropout rate of 30 the sample size is calculated to be 16 participants per group This calculation is based on a 95 confidence level Zα 196 and 80 power Zβ 084 across the three arms
10 Proposed Statistical Analysis
the data will be analyzed using Analysis of Variance ANOVA assuming no difference in baseline characteristic Next the relationship between continuous values will be assessed using the Pearson correlation test normally distributed data or the Spearman test data not normally distributed to determine how big the correlation is between these variables
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None