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IRCT20221019056245N4 IRCT 2026-08-05 Babol University of Medical Sciences Comparing one-hand and two-hand robotic glove exercises to improve hand movement in stroke patients Evaluating The effectiveness of bilateral versus unilateral robotic glove-assisted training on hand motor function and functional independence in stroke patients with unilateral involvement 2026-08-22 anticipated 44 Recruiting https://irct.ir/trial/88207 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This study does not have any unique design features beyond those already described in the previous sections, Randomization description: Eligible participants will be randomly allocated to either the bilateral robotic glove training group or the unilateral robotic glove training group using block randomization after obtaining informed consent. The unit of randomization will be the individual participant. A computer-generated random sequence will be used for randomization. Allocation concealment will be ensured using sealed, opaque, sequentially numbered envelopes, Blinding description: Due to the nature of the intervention, complete blinding of participants and therapists is not feasible. Participants will not be aware of their assigned group prior to the initiation of the intervention; however, they will become aware of the type of training after the intervention begins. Outcome assessors will be blinded to group allocation. In addition, statistical analysis will be performed by an analyst who is blinded to group allocation. N/A Ischemic stroke. Intervention group:Group 1 (Bilateral training using a robotic glove):Participants in this group will receive 12 rehabilitation sessions over one month (three sessions per week). Each session consists of two phases:1.Ten minutes of conventional physiotherapy including stretching, weight-bearing, and range of motion exercises 2. Robotic glove training consisting of two types of exercises:1.Finger opening and closing 2.Finger opposition movements. Each exercise will be repeated 100 times. The robotic glove exercises are performed with both hands simultaneously.Group 2 (Unilateral training using a robotic glove):Participants in this group will receive 12 rehabilitation sessions similar to Group 1. The session sequence and duration are the same (ten minutes of physiotherapy followed by robotic glove training). The difference is that robotic glove exercises are performed only with the affected hand, including finger opening and closing and finger opposition, each repeated 100 times.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Khodabakhsh Javanshir
Babol University of Medical Sciences,Ganjafrooz St., Babol
Babol Iran (Islamic Republic of) 471767745 +98 11 3219 9592 Khodabakhshjavanshir@gmail.com Babol University of Medical Sciences scientific Khodabakhsh Javanshir
Babol University of Medical Sciences, Ganjafrooz St, Babol
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 9592 Khodabakhshjavanshir@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Patients with ischemic stroke At least three months have passed since the onset of stroke Age between 20 and 75 years The patient must be able to understand and follow the therapists instructions as assessed by the Minimal-Mental State Examination No severe spasticity(Modified Ashworth Scale) 20 years 75 years Both Patients with a history of other neurological disorders, such as peripheral polyneuropathy, will be excluded from the study. Patients with a history of fracture of the upper limb or hand will be excluded from the study. Patients who are simultaneously participating in other pharmacological or rehabilitation studies will be excluded from the study. Patients who have received botulinum toxin injections within the past three months will be excluded from the study. I63 Cerebral infarction Rehabilitation Intervention group:Group 1 (Bilateral training using a robotic glove):Participants in this group will receive 12 rehabilitation sessions over one month (three sessions per week). Each session consists of two phases:1.Ten minutes of conventional physiotherapy including stretching, weight-bearing, and range of motion exercises 2. Robotic glove training consisting of two types of exercises:1.Finger opening and closing 2.Finger opposition movements. Each exercise will be repeated 100 times. The robotic glove exercises are performed with both hands simultaneously.Group 2 (Unilateral training using a robotic glove):Participants in this group will receive 12 rehabilitation sessions similar to Group 1. The session sequence and duration are the same (ten minutes of physiotherapy followed by robotic glove training). The difference is that robotic glove exercises are performed only with the affected hand, including finger opening and closing and finger opposition, each repeated 100 times. N this study, upper limb motor function is considered the primary outcome and will be assessed using the Upper Extremity section of the Fugl-Meyer Assessment (FMA-UE). Assessments will be performed before and after the intervention period. Timepoint: Primary outcome will be assessed at two time points: before the intervention and immediately after completion of the intervention period. Method of measurement: Upper limb motor function will be measured using the Upper Extremity section of the Fugl-Meyer Assessment (FMA-UE). All assessments will be performed by a trained and independent assessor who is blinded to group allocation, before and after the intervention. The secondary outcome of this study is functional independence, which will be assessed using the Functional Independence Measure (FIM). This measure reflects the level of independence in activities of daily living and will be evaluated before and after the intervention period. Timepoint: The secondary outcome will be assessed at two time points: before the intervention and immediately after completion of the intervention period. Method of measurement: Functional independence as the secondary outcome will be measured using the Functional Independence Measure (FIM). Assessments will be conducted by a trained and independent assessor blinded to group allocation, before and after the intervention. Babol University of Medical Sciences Approved 2025-12-08 Ethics Committee of Babol University of Medical Sciences Ganj afrooz St. Babol Mazandaran Iran (Islamic Republic of)