Clinical Efficacy of Exoskeleton Robot-Assisted Rehabilitation on Lower Limb Functional Recovery in Elderly Patients With Hip Fracture

NCT ID: NCT07323147

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-01
• Study Completion Date: 2026-11-30

Brief Summary

With the intensification of population aging, hip fracture, as a common bone disease, is seeing an increasing incidence rate among the elderly population. Traditional rehabilitation training methods can no longer fully meet the functional recovery needs of elderly patients with hip fractures. Due to their wearability and intelligence, exoskeleton robots provide an innovative solution for rehabilitation training. This study aims to explore the application effects of exoskeleton robots in postoperative rehabilitation for elderly patients with hip fractures by utilizing exoskeleton robot-assisted rehabilitation training for elderly hip surgery patients. The focus is on its improvements in motor ability, balance ability, and pain levels, while also assessing its impact on patients' overall quality of life and the prevention of complications.

Conditions

Hip Fracture; Geriatrics; Lower Extremity Dysfunction; Postoperative Rehabilitation; Gait Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention Group

Training with exoskeleton+Conventional rehabilitation program

Group Type: EXPERIMENTAL

Exoskeleton

Intervention Type: DEVICE

1. Postural Adaptation Training: With exoskeleton support, the patient transitions from a lying or sitting position to an upright stance and maintains this posture for a prescribed duration.

2. Range of Motion (ROM) and Flexibility Training: The robot guides the patient's lower limbs (hip, knee, and ankle joints) through passive, large-amplitude flexion and extension movements within a safe range.

3. Muscle Reactivation and Low-Intensity Strengthening: With robotic assistance, the patient actively attempts to execute joint flexion and extension movements. The exoskeleton provides adjustable assistance levels proportionate to the patient's muscular capacity.

Control Group

Conventional rehabilitation program

Group Type: ACTIVE_COMPARATOR

Conventional rehabilitation program

Intervention Type: OTHER

1. Based on the patient's general condition and baseline status, ankle pumps, and isometric contractions of the quadriceps and gluteus medius will be performed progressively according to current international and domestic rehabilitation guidelines; followed by initiation of knee extension exercises, hip abduction exercises of the affected limb, and bridge exercises;

2. Once the patient's physical capacity has recovered to a relatively stable level, progressive resistance training for the quadriceps, hamstrings, and gluteal muscles will be gradually introduced, along with concurrent strength training for both upper limbs and the unaffected lower limb;

3. Depending on the patient's rehabilitation progress, training in position transfer, standing, and gait will be initiated; traditional physical rehabilitation modalities such as therapeutic cycling, electrical stimulation, and medium-frequency therapy devices may also be incorporated.

Interventions

Exoskeleton

1. Postural Adaptation Training: With exoskeleton support, the patient transitions from a lying or sitting position to an upright stance and maintains this posture for a prescribed duration.

2. Range of Motion (ROM) and Flexibility Training: The robot guides the patient's lower limbs (hip, knee, and ankle joints) through passive, large-amplitude flexion and extension movements within a safe range.

3. Muscle Reactivation and Low-Intensity Strengthening: With robotic assistance, the patient actively attempts to execute joint flexion and extension movements. The exoskeleton provides adjustable assistance levels proportionate to the patient's muscular capacity.

Intervention Type: DEVICE

Conventional rehabilitation program

1. Based on the patient's general condition and baseline status, ankle pumps, and isometric contractions of the quadriceps and gluteus medius will be performed progressively according to current international and domestic rehabilitation guidelines; followed by initiation of knee extension exercises, hip abduction exercises of the affected limb, and bridge exercises;

2. Once the patient's physical capacity has recovered to a relatively stable level, progressive resistance training for the quadriceps, hamstrings, and gluteal muscles will be gradually introduced, along with concurrent strength training for both upper limbs and the unaffected lower limb;

3. Depending on the patient's rehabilitation progress, training in position transfer, standing, and gait will be initiated; traditional physical rehabilitation modalities such as therapeutic cycling, electrical stimulation, and medium-frequency therapy devices may also be incorporated.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Aged 65 years or older, regardless of gender.

Diagnosed with a unilateral hip fracture resulting from low-energy trauma by imaging (X-ray/CT), and having undergone surgical treatment (internal fixation or arthroplasty).

The participant or their legal guardian understands and agrees to participate in the clinical trial and is willing to provide voluntary written informed consent.

Exclusion Criteria

Life expectancy of less than 6 months.

History of neurological disorders such as prior stroke, spinal cord injury, Parkinson's disease, or myasthenia gravis.

Severe joint contractures, deformities, or heterotopic ossification in the lower limbs that would prevent proper device fitting.

Body weight exceeding the device's maximum load capacity (>100 kg).

Height outside the adjustable range of the device.

Presence of a pathological fracture or multiple fragility fractures.

Presence of severe osteoarthritis or trauma in the contralateral lower limb that significantly impairs function.

Comorbidities including active malignancy or systemic infection.

Comorbidities such as thromboembolic disease in the lower limbs, pneumonia, or pressure injuries (bedsores).

Comorbidities affecting rehabilitation capacity, including unstable angina, heart failure, severe sequelae of stroke, severe chronic obstructive pulmonary disease (COPD), or severe hepatic/renal dysfunction.

Poor compliance, cognitive impairment preventing cooperation, or diagnosed psychiatric disorders such as depression or anxiety.

Participation in any other clinical trial within the 3 months prior to screening.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hai bao

OTHER

Sponsor Role: lead

Responsible Party

Hai bao

Attending Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Beijing Jishuitan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

JST-IIT-2025086

Identifier Type: -

Identifier Source: org_study_id