Clinical trial NCT06933147: Resistance Training and Constrained Induced Movement Therapy on Upper Extremity Motor Recovery and Quality of Life in Sub-acute Stroke Patients
Official title: Comparative Effects of Resistance Training and Constrained Induced Movement Therapy on Upper Extremity Motor Recovery and Quality of Life in Sub-acute Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Action Research Arm Test
Constraint-Induced Movement Therapy
Fugl-Meyer Assessment
Quality of Life
Resistance Training
Stroke Rehabilitation
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 64
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: This study explored two common rehabilitation strategies-Constraint-Induced Movement Therapy (CIMT) and Resistance Training (RT)-to help stroke survivors improve movement and function in their weaker arm. Stroke can often lead to reduced mobility in one arm, which affects a person's independence and quality of life. This randomized clinical trial involved 64 patients between the ages of 40 to 60 who had experienced a stroke and were in the sub-acute phase of recovery. Participants were randomly assigned to one of two groups: one group received CIMT and the other received RT. The CIMT group had their unaffected arm restrained for 6 hours per day and completed 3 hours of supervised exercises using the affected arm. The RT group participated in structured strength training using weights to target shoulder, elbow, and wrist muscles. Both groups were treated five days a week for 12 weeks. Throughout the study, researchers assessed participants using three tools: the Action Research Arm Test (ARAT) for arm function, the Fugl-Meyer Assessment (FMA) for motor recovery, and the Stroke-Specific Quality of Life Scale (SS-QOL) for overall well-being. These assessments were conducted at baseline, week 4, week 8, and week 12.

Detailed description: This randomized clinical trial was designed to evaluate and compare the effects of two rehabilitation techniques-Constraint-Induced Movement Therapy (CIMT) and Resistance Training (RT)-on motor recovery and quality of life in patients recovering from sub-acute stroke. Stroke survivors commonly experience upper limb impairments that hinder their ability to perform activities of daily living (ADLs). Traditional therapy approaches often focus on general mobility, but targeted interventions like CIMT and RT have shown promise in enhancing specific motor functions and promoting neuroplasticity. A total of 64 stroke patients, aged 40-60 years, who had mild to moderate upper limb impairment were included. They were randomly assigned into two equal groups. Group A received CIMT, which involved constraining the unaffected arm for 6 hours daily and performing 3 hours of functional task-oriented training with the affected limb. Group B underwent RT, a progressive strengthening protocol that included concentric contractions of the shoulder, elbow, and wrist using weighted cuffs adjusted according to each patient's one-repetition maximum (1RM). Both groups received standard physiotherapy and were given home exercise programs. Patients were assessed using the Action Research Arm Test (ARAT), Fugl-Meyer Assessment (FMA), and Stroke-Specific Quality of Life Scale (SS-QOL) at four intervals: baseline, 4th week, 8th week, and 12th week. Data were analyzed using SPSS version 24. The study was ethically approved, and informed consent was obtained from all participants. It adhered to the ethical guidelines of the University of Lahore. Patients were assured of confidentiality, voluntary participation, and the right to withdraw at any point. No adverse effects were reported from either intervention.

Eligibility criteria: Inclusion Criteria:

* Patient having age between 40-60 years
* Both gender were included
* Patient diagnosed with hemiparesis having grade 1 or 2 using Modified Ashworth Scale (MAS)
* Participant able to sit independently for 60 min
* Patients experiencing functional limitations in upper limb motor function

Exclusion Criteria:

* Participants with severe aphasia, severe shoulder pain affecting therapy or any comorbid condition that could limit UE function, visual or hearing impairment
* Uncontrolled pain or spasticity in the affected arm
* History of shoulder instability or major orthopedic surgery in the affected arm

Primary outcomes:
measure: Action Research Arm Test (ARAT)
timeFrame: Baseline, Week 4, Week 8, and Week 12
Secondary outcomes:
measure: Fugl-Meyer Assessment (FMA) - Upper Extremity Section
timeFrame: Baseline, Week 4, Week 8, and Week 12
measure: Stroke-Specific Quality of Life Scale (SS-QOL)
timeFrame: Baseline, Week 4, Week 8, and Week 12
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: The University of Lahore Teaching Hospital
Study officials:
References:
citation: Gracies JM, Pradines M, Ghedira M, Loche CM, Mardale V, Hennegrave C, Gault-Colas C, Audureau E, Hutin E, Baude M, Bayle N; Neurorestore Study Group. Guided Self-rehabilitation Contract vs conventional therapy in chronic stroke-induced hemiparesis: NEURORESTORE, a multicenter randomized controlled trial. BMC Neurol. 2019 Mar 12;19(1):39. doi: 10.1186/s12883-019-1257-y.
citation: Lang CE, Strube MJ, Bland MD, Waddell KJ, Cherry-Allen KM, Nudo RJ, Dromerick AW, Birkenmeier RL. Dose response of task-specific upper limb training in people at least 6 months poststroke: A phase II, single-blind, randomized, controlled trial. Ann Neurol. 2016 Sep;80(3):342-54. doi: 10.1002/ana.24734. Epub 2016 Aug 16.