StrokeNCT05049018
Upper Extremity Training for Improving Balance Control Post-Stroke
A study testing Traditional Physical Therapy Program and ArmeoSpring Virtual Reality Device (Upper Extremity Training Device with Virtual Reality Technology) in people with Stroke, run by Umm Al-Qura University at 1 site in Saudi Arabia.
Trial summary
Postural balance control is based on complex mechanisms involving several sensory and motor systems. Maintaining postural equilibrium requires muscle activation to oppose the balance threats. Read more about this study
- Who is it for?
- Ages 50 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- Traditional Physical Therapy Program and ArmeoSpring Virtual Reality Device (Upper Extremity Training Device with Virtual Reality Technology)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jan 2021to 10 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The inclusion criteria were: adult participants aged 50 to 60 years with a confirmed diagnosis of chronic stroke (at least 6 months following the stroke incidence) secondary to ischemia or hemorrhage. The degree of spasticity of the affected upper limb ranged between 1, 1+ and 2 according to Modified Ashworth Scale. All participants were cognitively able to understand and follow instructions. All participants did not receive other treatments to improve the functions of the affected upper limb except study treatment. During the study, participants were not receiving other interventions specialized to improve postural balance control.
Who cannot join
- The exclusion criteria were: any participant with a cognitive reduction (< 23 points based on Mini-Mental State Examination scale). (15) Participants with fixed muscle contractures, joints' stiffness, and who had major rotational malalignment in the affected upper and lower limbs. Participants with vestibular, and cerebellar problems were also excluded from this study. Other exclusion criteria were participants with: visual, auditory, and perceptual diseases/impairment, uncontrolled seizures, and those who received botulinum toxin (six months before the beginning of the study) or muscle-tone control medication (three months before the beginning of the study).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Upper Extremity Training on Balance Control in Patients with Chronic Stroke: a Randomized Control Trial
Postural balance control is based on complex mechanisms involving several sensory and motor systems. Maintaining postural equilibrium requires muscle activation to oppose the balance threats. Stroke may be associated with a variety of deficits, including impaired upper limb functions , poor postural stability, impaired reactive balance control, and delayed responses to external balance perturbations. Individuals with stroke are at high risk for falls in all post-stroke stages. Falls may have long-term serious consequences and can lead to more disability. Upper extremity movements have a relevant contribution in controlling balance and enhance the ankle and hip strategies for maintaining upright postural stability among healthy adults. Upper extremities movements also, constitute important elements in both equilibrium and protective reactions. Appropriate corrective responses of both the upper and lower extremities are essential to regain balance control and reduce the risk of falls. More studies are required to know about the impact of arm movements on postural balance control in individuals post-stroke. The purpose of this study is to investigate the effect of the improvement of the upper extremity functions on postural balance control in patients with stroke.
Read the detailed description
Stroke is defined as rapidly developing clinical signs of focal (or global) disturbance of cerebral function, leading to death, with no apparent cause other than that of vascular origin. It considered the biggest burden cause of disability all over the world, 16 million people suffer from a stroke every year with great economic and social repercussions. Following a stroke, a number of impairments may influence the patient's ability to perform functional activities. These include weakness, alterations in tone, sensory loss, uncoordinated response, reduced balance mechanisms, and walking problems. Upper limb involvement is usually more pronounced than the lower limb. The effects of stroke on the upper limb functions are common and a significant cause of long-term disability. Balance impairment is one of the most common deficits in patients post-stroke. After a stroke, balance abilities are reduced due to abnormal muscle activity and asymmetric posture. Impaired Balance not only increases the risk of falls but also adversely affects physical activity and social participation. The influence of arm movements on postural control only appears to be evident in case of impairs upper extremity functional performance. Arm movements play a functional role in postural stability during standing and walking. Arm and hand movements can also serve a protective role to prevent head injury in case of falling. Rehabilitation programs aiming for improving upper extremity impairments and improving balance performance can reduce the fall risk in individuals with stroke. Recently, virtual reality-based training exercises, are used to improve upper limb functions, balance, gait, and quality of life in stroke survivors. Many studies supported that virtual reality-based programs are suitable and have a potential value for patients with stroke. The purpose of this study is to investigate the impact of the improvement of the upper motor abilities by using virtual reality-based training on balance control in patients with chronic stroke.
- Conditions
- Stroke
- Being tested
- Traditional Physical Therapy Program, ArmeoSpring Virtual Reality Device (Upper Extremity Training Device with Virtual Reality Technology)
- Keywords
- Upper Extremity Functions, Balance Control, Postural Stability, Virtual Reality, Conventional Exercise Training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Physical Therapy ProgramOther
This intervention included:
- Strengthening and facilitation exercises for the affected upper extremity muscles.
- Stretching and mobilization exercises for the affected upper extremity muscles and joints.
- Postural reactions exercises.
- Facilitation of arm-reaching and arm-hand skills for the affected upper extremity.
- Facilitation of manipulative tasks (grasp and release activities) for the affected upper extremity.
- Training of daily living activities for the upper extremities.
ArmeoSpring Virtual Reality Device (Upper Extremity Training Device with Virtual Reality Technology)Device
ArmeoSpring virtual Reality Equipment is a functional upper extremity rehabilitation device that provides specific therapy with augmented feedback. The ArmeoSpring instrument facilitates intensive task-oriented upper extremity therapy after stroke, traumatic brain injury, or other neurological diseases and injuries. It combines adjustable arm support, with augmented feedback and a large 3 D workspace that allows functional therapy exercises in a virtual reality environment.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Participants who participated in the control group received a traditional physical therapy program for two hours. It included two parts, each of them was for one hour and 15 minutes rest in between. The first part included: muscle strengthening and facilitation exercises, stretching exercises, and postural reactions exercises. The second part included: functional exercise for facilitation of arm-reaching and arm-hand skills, manipulative tasks (grasping and release activities), and daily living activities for the affected upper limb.
The traditional treatment program was applied for both groups by therapists, experienced in stroke rehabilitation. It was carried out three sessions per week for twelve successive weeks. Receives: Other: Traditional Physical Therapy Program |
| Experimental Group | Experimental | Participants in the experimental group received two hours treatment program that included three parts, the first and the second parts (similar to that were applied for participants in the control group). These two parts were applied for one hour followed by 15 minutes rest, then the third part was applied for one hour. The third part of the program was a one-hour virtual reality intervention program by using (ArmeoSpring) virtual reality equipment to simulate a range of upper limb tasks that facilitate arm activities, manipulative skills, and daily living tasks through using different interactive games and soft-wares.
The traditional treatment part of the program was applied by therapists, experienced in stroke rehabilitation. The virtual reality part of the program was applied by other experienced physiotherapists, who were well trained in using the (ArmeoSpring) System. All three parts of the program were carried out three sessions per week for twelve successive weeks. Receives: Other: Traditional Physical Therapy Program; Device: ArmeoSpring Virtual Reality Device (Upper Extremity Training Device with Virtual Reality Technology) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the score of Fugl-Meyer Assessment Scale of Upper-Extremity (scale that assess the change in upper extremity motor functions)
The Fugl-Meyer Assessment of Upper Extremity (FMA-UE) is a stroke-specific, performance-based impairment index. It measures the movement, coordination and reflex action of the shoulder, elbow, forearm, wrist and hand. The scale includes 33 items divided into 4 subscales: (A) shoulder/elbow, 18 items, (B) wrist, 5 items, (C) hand, 7 items, and (D) coordination/speed, 3 items. Each item is scored on an ordinal 3-point scale, where 2 points are assigned when the movement is performed fully, 1 point when performed partially, and 0 points when the movement cannot be performed. A total score of 66 indicates better sensorimotor function. Thus, the higher the score a patient will get after completion of the treatment program compared to the baseline score, the better the improvement in upper extremity motor functions.
Measured: [Data collected at baseline, and 12 weeks after intervention commencement.] (i.e. Difference between Fugl-Meyer Assessment Scale Score of Upper-Extremity at both baseline and completion of 12 weeks of intervention)
Change in the score of Balance Subscale of the Fugl-Meyer Test (scale that designed to evaluate balance impairment after stroke.)
Balance Subscale of the Fugl-Meyer Test is designed to evaluate balance impairment after stroke. It contains 7 items, 3 for sitting and 4 for standing. These items are sitting without support, parachute reaction (both sides), standing with and without support, unilateral stance (both sides). The seven items are rated on a 3-point scale (0-2). The total score is ranged from 0 to 14. This test is a valid and reliable clinical balance measures at different post-stroke stages of recovery.
Measured: [Data collected at baseline, and 12 weeks after intervention commencement.] (i.e. Difference between the scores of Balance Subscale of the Fugl-Meyer Test at both baseline and completion of 12 weeks of intervention)
Change in the Overall Stability Indices {percentage value (%)} for Postural Stability Test (test that assess the change in postural stability)
The Biodex Balance System will be used to assess the change in the Overall Stability Indices of the Postural Stability Test. The test includes measurement of the following indices: overall stability index, anteroposterior index and mediolateral index which represents the patient's ability to control his postural balance stability in all directions. High values % represent less stability and the patient has difficulty in balance control. On the other hand lower values are indicative of a better balance control.
Measured: [Data collected at baseline, and 12 weeks after intervention commencement.](i.e. Difference between the overall stability indices score at both baseline and completion of 12 weeks of intervention)
Secondary outcomes (2)
Change in the Overall Directional Control Index {percentage value (%)}, for Limit of Stability Test (test that assess the change in balance ability)
The Biodex Balance System was used to assess the change in the Overall Directional Control Index of the Limit of Stability Test. This test involved measurement of overall directional control which represented as a percentage value (%). The higher scores will indicate better balance control.
Measured: [Data collected at baseline, and 12 weeks after intervention commencement.](i.e. Difference between the overall directional control index at both baseline and completion of 12 weeks of intervention)
Change in the Total Time of Control {seconds} for Limit of Stability Test (test that assess the change in total time required to complete limit of Stability Test)
The Biodex Balance System was used to assess the change in the Time of Control of the Limit of Stability Test. This test involved measurement of total time required to complete the test (seconds), improvement in this parameter requires minimizing the time recorded to complete the test.
Measured: [Data collected at baseline, and 12 weeks after intervention commencement.](i.e. Difference between the total time required to complete limit of stability test at both baseline and completion of 12 weeks of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start1 Jan 2021
- Primary completion31 Jan 2022
- Study completion10 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umm Al-Qura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Mohamed Abd El Kafy, Umm Al-Qura University
- Investigators
- Ehab M Abd El Kafy, PhD, Principal investigator, Faculty of Applied Medical Sciences - Umm Al Qura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049018
- Sponsor's protocol ID
- 14-MED98-10
- Status last verified
- Sep 2021
- First submitted
- 9 Sep 2021
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: * Individual participant data underlying published results only. * The data available is Case-by-case basis at the discretion of Primary Sponsor
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Upper Extremity Training on Balance Control in Patients with Chronic Stroke: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05049018
- Acronym / sponsor ID
- 14-MED98-10
- Conditions
- Stroke
- Keywords
- Upper Extremity Functions, Balance Control, Postural Stability, Virtual Reality, Conventional Exercise Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Umm Al-Qura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postural balance control is based on complex mechanisms involving several sensory and motor systems. Maintaining postural equilibrium requires muscle activation to oppose the balance threats. Stroke may be associated with a variety of deficits, including impaired upper limb functions , poor postural stability, impaired reactive balance control, and delayed responses to external balance perturbations. Individuals with stroke are at high risk for falls in all post-stroke stages. Falls may have long-term serious consequences and can lead to more disability. Upper extremity movements have a relevant contribution in controlling balance and enhance the ankle and hip strategies for maintaining upright postural stability among healthy adults. Upper extremities movements also, constitute important elements in both equilibrium and protective reactions. Appropriate corrective responses of both the upper and lower extremities are essential to regain balance control and reduce the risk of falls. More studies are required to know about the impact of arm movements on postural balance control in individuals post-stroke. The purpose of this study is to investigate the effect of the improvement of the upper extremity functions on postural balance control in patients with stroke.
Detailed description
Stroke is defined as rapidly developing clinical signs of focal (or global) disturbance of cerebral function, leading to death, with no apparent cause other than that of vascular origin. It considered the biggest burden cause of disability all over the world, 16 million people suffer from a stroke every year with great economic and social repercussions. Following a stroke, a number of impairments may influence the patient's ability to perform functional activities. These include weakness, alterations in tone, sensory loss, uncoordinated response, reduced balance mechanisms, and walking problems. Upper limb involvement is usually more pronounced than the lower limb. The effects of stroke on the upper limb functions are common and a significant cause of long-term disability. Balance impairment is one of the most common deficits in patients post-stroke. After a stroke, balance abilities are reduced due to abnormal muscle activity and asymmetric posture. Impaired Balance not only increases the risk of falls but also adversely affects physical activity and social participation. The influence of arm movements on postural control only appears to be evident in case of impairs upper extremity functional performance. Arm movements play a functional role in postural stability during standing and walking. Arm and hand movements can also serve a protective role to prevent head injury in case of falling. Rehabilitation programs aiming for improving upper extremity impairments and improving balance performance can reduce the fall risk in individuals with stroke. Recently, virtual reality-based training exercises, are used to improve upper limb functions, balance, gait, and quality of life in stroke survivors. Many studies supported that virtual reality-based programs are suitable and have a potential value for patients with stroke. The purpose of this study is to investigate the impact of the improvement of the upper motor abilities by using virtual reality-based training on balance control in patients with chronic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Traditional Physical Therapy ProgramParticipants who participated in the control group received a traditional physical therapy program for two hours. It included two parts, each of them was for one hour and 15 minutes rest in between. The first part included: muscle strengthening and facilitation exercises, stretching exercises, and postural reactions exercises. The second part included: functional exercise for facilitation of arm-reaching and arm-hand skills, manipulative tasks (grasping and release activities), and daily living activities for the affected upper limb. The traditional treatment program was applied for both groups by therapists, experienced in stroke rehabilitation. It was carried out three sessions per week for twelve successive weeks. |
| Experimental Group | Experimental | Other: Traditional Physical Therapy Program, Device: ArmeoSpring Virtual Reality Device (Upper Extremity Training Device with Virtual Reality Technology)Participants in the experimental group received two hours treatment program that included three parts, the first and the second parts (similar to that were applied for participants in the control group). These two parts were applied for one hour followed by 15 minutes rest, then the third part was applied for one hour. The third part of the program was a one-hour virtual reality intervention program by using (ArmeoSpring) virtual reality equipment to simulate a range of upper limb tasks that facilitate arm activities, manipulative skills, and daily living tasks through using different interactive games and soft-wares. The traditional treatment part of the program was applied by therapists, experienced in stroke rehabilitation. The virtual reality part of the program was applied by other experienced physiotherapists, who were well trained in using the (ArmeoSpring) System. All three parts of the program were carried out three sessions per week for twelve successive weeks. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The inclusion criteria were: adult participants aged 50 to 60 years with a confirmed diagnosis of chronic stroke (at least 6 months following the stroke incidence) secondary to ischemia or hemorrhage. The degree of spasticity of the affected upper limb ranged between 1, 1+ and 2 according to Modified Ashworth Scale. All participants were cognitively able to understand and follow instructions. All participants did not receive other treatments to improve the functions of the affected upper limb except study treatment. During the study, participants were not receiving other interventions specialized to improve postural balance control.
Key exclusion criteria (1 listed)
- The exclusion criteria were: any participant with a cognitive reduction (< 23 points based on Mini-Mental State Examination scale). (15) Participants with fixed muscle contractures, joints' stiffness, and who had major rotational malalignment in the affected upper and lower limbs. Participants with vestibular, and cerebellar problems were also excluded from this study. Other exclusion criteria were participants with: visual, auditory, and perceptual diseases/impairment, uncontrolled seizures, and those who received botulinum toxin (six months before the beginning of the study) or muscle-tone control medication (three months before the beginning of the study).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Physical Therapy ProgramThis intervention included: * Strengthening and facilitation exercises for the affected upper extremity muscles. * Stretching and mobilization exercises for the affected upper extremity muscles and joints. * Postural reactions exercises. * Facilitation of arm-reaching and arm-hand skills for the affected upper extremity. * Facilitation of manipulative tasks (grasp and release activities) for the affected upper extremity. * Training of daily living activities for the upper extremities. | Other | Control Group, Experimental Group |
| ArmeoSpring Virtual Reality Device (Upper Extremity Training Device with Virtual Reality Technology)ArmeoSpring virtual Reality Equipment is a functional upper extremity rehabilitation device that provides specific therapy with augmented feedback. The ArmeoSpring instrument facilitates intensive task-oriented upper extremity therapy after stroke, traumatic brain injury, or other neurological diseases and injuries. It combines adjustable arm support, with augmented feedback and a large 3 D workspace that allows functional therapy exercises in a virtual reality environment. | Device | Experimental Group |
Primary outcome
Change in the score of Fugl-Meyer Assessment Scale of Upper-Extremity (scale that assess the change in upper extremity motor functions)
Time frame: [Data collected at baseline, and 12 weeks after intervention commencement.] (i.e. Difference between Fugl-Meyer Assessment Scale Score of Upper-Extremity at both baseline and completion of 12 weeks of intervention)
The Fugl-Meyer Assessment of Upper Extremity (FMA-UE) is a stroke-specific, performance-based impairment index. It measures the movement, coordination and reflex action of the shoulder, elbow, forearm, wrist and hand. The scale includes 33 items divided into 4 subscales: (A) shoulder/elbow, 18 items, (B) wrist, 5 items, (C) hand, 7 items, and (D) coordination/speed, 3 items. Each item is scored on an ordinal 3-point scale, where 2 points are assigned when the movement is performed fully, 1 point when performed partially, and 0 points when the movement cannot be performed. A total score of 66 indicates better sensorimotor function. Thus, the higher the score a patient will get after completion of the treatment program compared to the baseline score, the better the improvement in upper extremity motor functions.
Change in the score of Balance Subscale of the Fugl-Meyer Test (scale that designed to evaluate balance impairment after stroke.)
Time frame: [Data collected at baseline, and 12 weeks after intervention commencement.] (i.e. Difference between the scores of Balance Subscale of the Fugl-Meyer Test at both baseline and completion of 12 weeks of intervention)
Balance Subscale of the Fugl-Meyer Test is designed to evaluate balance impairment after stroke. It contains 7 items, 3 for sitting and 4 for standing. These items are sitting without support, parachute reaction (both sides), standing with and without support, unilateral stance (both sides). The seven items are rated on a 3-point scale (0-2). The total score is ranged from 0 to 14. This test is a valid and reliable clinical balance measures at different post-stroke stages of recovery.
Change in the Overall Stability Indices {percentage value (%)} for Postural Stability Test (test that assess the change in postural stability)
Time frame: [Data collected at baseline, and 12 weeks after intervention commencement.](i.e. Difference between the overall stability indices score at both baseline and completion of 12 weeks of intervention)
The Biodex Balance System will be used to assess the change in the Overall Stability Indices of the Postural Stability Test. The test includes measurement of the following indices: overall stability index, anteroposterior index and mediolateral index which represents the patient's ability to control his postural balance stability in all directions. High values % represent less stability and the patient has difficulty in balance control. On the other hand lower values are indicative of a better balance control.
2 secondary outcomes
Change in the Overall Directional Control Index {percentage value (%)}, for Limit of Stability Test (test that assess the change in balance ability)
Time frame: [Data collected at baseline, and 12 weeks after intervention commencement.](i.e. Difference between the overall directional control index at both baseline and completion of 12 weeks of intervention)
Change in the Total Time of Control {seconds} for Limit of Stability Test (test that assess the change in total time required to complete limit of Stability Test)
Time frame: [Data collected at baseline, and 12 weeks after intervention commencement.](i.e. Difference between the total time required to complete limit of stability test at both baseline and completion of 12 weeks of intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Individual participant dataSharing planned: Yes. * Individual participant data underlying published results only. * The data available is Case-by-case basis at the discretion of Primary Sponsor
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ehab M Abd El Kafy, PhD principal investigator
Faculty of Applied Medical Sciences - Umm Al Qura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Physical Therapy Program and ArmeoSpring Virtual Reality Device (Upper Extremity Training Device with Virtual Reality Technology) in people with Stroke, run by Umm Al-Qura University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the score of Fugl-Meyer Assessment Scale of Upper-Extremity (scale that assess the change in upper extremity motor functions) (time frame: [Data collected at baseline, and 12 weeks after intervention commencement.] (i.e. Difference between Fugl-Meyer Assessment Scale Score of Upper-Extremity at both baseline and completion of 12 weeks of intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.