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

NCT07323147 | Enrolling By Invitation

• 1 other identifier: JST-IIT-2025086
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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

Keywords

Exoskeleton Robot; Robotic Rehabilitation; Wearable Devices; Randomized Controlled Trial; Multicenter Study; Recovery of Function; Harris Hip Score

Outcome Measures

Primary Outcomes (1)

• Harris Hip Score

  Assessed using the Harris Hip Score (HHS), a disease-specific instrument widely used for evaluating outcomes following hip surgery or in hip pathology. The scale assesses the patient across four domains: pain (44 points), function (47 points), range of motion (5 points), and absence of deformity (4 points). The total score ranges from 0 to 100 points. A higher score indicates better hip joint function and less disability. The reported value is the total HHS score (points).

  1-month post-intervention (T1), 3-month post-intervention (T2).

Secondary Outcomes (7)

• Berg Balance Scale

  1-month post-intervention (T1), 3-month post-intervention (T2)

• Timed Up and Go Test

  1-month post-intervention (T1), 3-month post-intervention (T2).

• 6-Minute Walk Test

  1-month post-intervention (T1), 3-month post-intervention (T2).

• Visual Analogue Scale (VAS)

  1-month post-intervention (T1), 3-month post-intervention (T2).

• Range of Motion Measurement

  1-month post-intervention (T1), 3-month post-intervention (T2).

Study Arms (2)

Intervention Group

EXPERIMENTAL

Training with exoskeleton+Conventional rehabilitation program

Device: Exoskeleton

Control Group

ACTIVE COMPARATOR

Conventional rehabilitation program

Other: Conventional rehabilitation program

Interventions

Exoskeleton 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.

Intervention Group

Conventional rehabilitation program 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.

Control Group

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hai bao: lead

Study Sites (1)

Beijing Jishuitan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100035, China

Location

MeSH Terms

Conditions

Hip Fractures; Mobility Limitation

Interventions

Exoskeleton Device

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician

Model Details: The target total sample size is 86 participants. A competitive enrollment model will be used, with no pre-set quota for individual study sites. All participating centers will collectively compete to achieve the overall recruitment target.

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: January 7, 2026
• Study Start: February 1, 2026
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)